BQ+ products for the U.S. market

Start with cleared product scope—not a catalog number alone.

BQ+ holds three FDA 510(k) clearances for defined I.V. administration and extension-set routes. Explore representative U.S. configurations, verify the applicable clearance and establishment, then let BQ+ prepare the exact product pathway.

Explore U.S. Configurations Check a Catalog Number

Representative BQ+ flow-regulated I.V. administration set

3 FDA 510(k) clearancesVerified in FDA’s official database

I.V. administration + extension routesExact applicability stays REF-specific

2 active 2026 FEIsSongjiang and Huaian establishments

FDA inspection recordMarch 26, 2025 · FDA 483: No

FDA 510(k) foundation

Three clearances. More than three products.

A 510(k) number identifies a cleared device scope, not one catalog item. Current commercial identifiers, device listings and manufacturing-site responsibilities are maintained separately and confirmed for the selected BQ+ REF.

K210381

I.V. Administration Set

FDA’s public summary identifies seven base models: four administration-set and three extension-set configurations.

Decision: August 14, 2021
Code: FPA · 21 CFR 880.5440
Examples: BQ-SYQ-001 to 004; BQ-YCG-017 to 019

Open FDA record →

K223645

I.V. Administration Set & I.V. Extension Set

FDA’s public summary identifies ten base models: six administration-set and four extension-set configurations.

Decision: May 18, 2023
Code: FPA · 21 CFR 880.5440
Examples: BQAS-0201 to 1203; BQES-MF01 to MF04

Open FDA record →

K242126

I.V. Administration Set

FDA records a Special 510(k) decision for BQ+ I.V. Administration Set. Exact current product-reference mapping is confirmed through the controlled listing register.

Decision: August 22, 2024
Code: FPA · 21 CFR 880.5440
Product drawings: Public gallery pending exact approved mapping

Open FDA record →

Representative cleared-model routes

See actual U.S. configurations before sending your reference.

These website-safe schematics were derived from BQ+ product drawings. Dimensions, tolerances, parts tables and controlled drawing details have been removed. They help buyers recognise the configuration; the source drawing and applicable 510(k) remain controlled.

K210381 examples

Three examples from the five-drawing local package. FDA’s public summary lists seven base models in this clearance.

BQ-YCG-018

Needle-free extension set

Straight extension route with needle-free valve.

BQ-SYQ-003

Needle-free administration set

Y-site and needle-free valve configuration route.

BQ-YCG-017

Multi-access extension set

T connector and needle-free valve extension route.

K223645 examples

Three representative examples from a complete local ten-drawing package that matches the ten base models listed in FDA’s public summary.

BQAS-0201

Administration set with back check valve

Clamp and back-check-valve administration route.

BQAS-0203

Flow-regulated filtered administration set

Flow regulator and 15 µm filter administration route.

BQES-MF03

Needle-free extension set

Extension route with needle-free Type Y access.

Why the old diagram catalog is not copied directly: its configuration drawings remain useful, but some 510(k) labels are outdated or misplaced. The U.S. page therefore reuses the visual language while rebuilding the regulatory mapping from the current FDA record and BQ+ listing register.

Popular U.S. sourcing routes

Start with the product family your catalog already uses.

U.S. buyers often work from an existing catalog reference. These routes show the configuration families BQ+ can review—not automatic equivalence and not a blanket regulatory claim.

I.V. administration sets

Basic administration setVented chamber, clamp, injection site and luer-connection routes.

Needle-free access setSingle- or multi-access configurations with the selected valve type.

Flow-regulated setFlow regulator positioned within the complete administration line.

Filtered administration setProduct-specific filter type, pore size and application review.

Stopcock & multi-access setBranching and access-point arrangements for defined workflows.

I.V. extension sets

Standard-bore extensionLength, tubing dimensions, clamps and end connections defined by REF.

Small- & microbore extensionReduced-bore routes for the required connection and fluid pathway.

Needle-free & multi-access extensionSingle-, dual- or multi-access arrangements with selected valve technology.

Filtered extension setFilter housing, pore size and upstream/downstream connections reviewed together.

Stopcock extension setThree-way stopcock and connection sequence configured as one finished line.

Neutral-pressure NFV

Negative-pressure NFV

Precision filters

Fluid dispensing connector

Pharmacy transfer tubing

Send what you already have: a U.S. catalog number, product link, drawing, photograph, sample or specification. BQ+ will return the closest controlled route and identify the gaps that still require confirmation.

FDA establishment and inspection evidence

Answer the questions U.S. buyers ask first.

Establishment registration, device listing, 510(k) clearance and inspection history are separate FDA records. One does not automatically prove the others.

ACTIVE 2026 ESTABLISHMENT RECORD

Songjiang · FEI 3013023255

FDA establishment record shown for BQ Plus Medical Co., Ltd., Shanghai Songjiang.

ACTIVE 2026 ESTABLISHMENT RECORD

Huaian · FEI 3036978618

FDA establishment record shown for BQ Plus Medical Co., Ltd., Huaian, Jiangsu.

FDA INSPECTION DATABASE

March 26, 2025 · FDA 483: No

The FDA inspection database records a Songjiang inspection with the field “FDA 483: No.” This wording is more precise than calling a facility “FDA approved.”

Regulatory boundaryFEI identifies an establishment. A 510(k) clears a defined device scope. Device listing connects commercial identifiers and roles. FDA inspection history describes an inspection record. BQ+ confirms all four for the exact product and supply route before making a customer commitment.

U.S. catalog and private-label experience

Experience is shown through the work we can perform.

BQ+ supports multi-SKU U.S. projects without publishing confidential customer names, logos, commercial terms or private product mappings.

Catalog cross-referenceStart from a U.S. catalog number, sample, drawing or specification.

Configuration engineeringMap components, dimensions and functions to a controlled BQ+ REF.

Private-label onboardingAlign brand roles, label, UDI, packaging, importer and listing responsibilities.

Regulatory confirmationConfirm the applicable 510(k), device listing, FEI and manufacturing route before release.

FAQ

Questions U.S. buyers ask before qualification.

Does BQ+ have its own 510(k) clearances?

Yes. FDA’s official database lists K210381, K223645 and K242126 for BQ Plus Medical Co., Ltd. Exact applicability is confirmed for the selected product reference.

Do three 510(k) numbers mean only three products?

No. The public summaries define multiple base models, and current device listings can contain additional commercial identifiers. The mapping must still be checked for each BQ+ REF.

Does BQ+ have an FEI?

FDA establishment records shown in this page identify active 2026 records for Songjiang, FEI 3013023255, and Huaian, FEI 3036978618.

Has BQ+ been inspected by FDA?

The FDA inspection database records a Songjiang inspection dated March 26, 2025 with “FDA 483: No.”

Can BQ+ match a major U.S. catalog number?

It can be used as the starting point for a controlled comparison. BQ+ will not claim identity or equivalence from the number or appearance alone.