The 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act)（Source: https://www.fda.gov/medical-devices）
When the FDA receive the 510(k) submission, they will assign the submission a unique number which is commonly referred to 510(k) number, or K number followed by 6 digits.
For example, K210281
The first two digits 21 show the submission is received in 2021, the last four digits 0281 represent the submission number.
When is 510(k) required？
The 510(k) is required for medium-risk devices (most Class II as well as some Class I and III) that have a predicate on the market which can be used to demonstrate the safety and effectiveness of the device. It’s not only required for new developed devices but also for devices that have been modified in a way that could impact safety or effectiveness. This could include changes to the:
- Design
- Components
- Materials
- Chemical composition
- Energy source
- Manufacturing process
- Intended use
What is Substantial Equivalence (SE)?
The SE has exact standards. Generally, it’s up to intended use and the technological characteristics of the two devices. Shortly the new device:
- has the same intended use as the predicate; and
- has the same technological characteristics as the predicate;
or
- has the same intended use as the predicate; and
- has different technological characteristics and does not raise different questions of safety and effectiveness; and
- the information submitted to FDA demonstrates that the new device is as safe and effective as the legally marketed device. (Source: https://www.fda.gov/medical-devices)
What advantages of 510(k)?
The 510(k) is not certificated like CE Mark Certificate, neither registered, it’s went for granted once FDA gives approval on 510(k) clearance after reviewing SE. It’s the most efficient way to launch new developed device to US markets.
BQ Plus Medical Co., Ltd., a professional medical device manufacturer focused on contract manufacturing of IV Administration and Extension Set, announced today that it has received 510(k) clearance for IV Administration Set and Extension Set from the U.S. Food and Drug Administration (FDA).
510(k) cleared IV Administration Sets and Extension Sets include 3-way Stopcock IV Administration Sets, Flow Regulator IV Administration Sets, Needle Free Valve IV Administration Sets, standard bore and microbore extension sets.
“We are pleased to have received 510(k) clearance”, said Ronia Cao, BQ Plus Medical CEO, “BQ Plus Medical was founded in 2015, as a recombination of medical business from former Nelson Techno Medical Co., Ltd, which started medical production in 2005. We have been doing OEM manufacturing for US customers since 2016. With our own 510(k), we are looking forward to bring more reliable quality and cost effective IV Administration Sets for use in hospitals, alternative site settings and long-term care facilities.”
