Product code MQB: 510(k) clearances and predicates
Product code MQB covers 0909FCE, 0909FCE-HS. FDA lists 424 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
424 clearances on file under product code MQB. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 31 |
| 2023 | 10 |
| 2024 | 8 |
| 2025 | 8 |
| 2026 so far | 3 |
Recent clearances
Newest MQB clearances in the FDA index, with applicant and decision date:
- K253800, 0909FCE, 0909FCE-HS, applicant Rayence Co., Ltd., decided 2026-07-31. FDA record
- K260820, VIVIX-S 4386W (FXRD-4386WA), applicant Vieworks Co., Ltd., decided 2026-06-18. FDA record
- K252996, Universal 1417PI, applicant Konica Minolta Healthcare Americas, Inc., decided 2026-06-12. FDA record
- K252911, Lux HD 2530 detector (Lux HD 2530), applicant Iray Imaging Technology (Haining) Limited, decided 2025-10-09. FDA record
- K250211, Yushan X-Ray Flat Panel Detector, applicant Innocare Optoelectronics Corp., decided 2025-07-22. FDA record
- K250665, SKR 3000, applicant Konica Minolta, Inc., decided 2025-06-17. FDA record
- K243734, Wireless/ Wired X-Ray Flat Panel Detectors, applicant Allengers Medical Systems Limited, decided 2025-04-18. FDA record
- K242770, EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG, applicant DRTECH Corporation, decided 2025-03-20. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include VIVIX-S 4386W (FXRD-4386WA), Universal 1417PI. Watch new MQB clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code MQB?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent MQB clearances include 0909FCE, 0909FCE-HS.
How many 510(k) clearances use product code MQB?
424 at the time this page was generated, from openFDA records.
How do I find a predicate device under MQB?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new MQB clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for MQB, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free MQB brief
Tell us where to send it. No card required.
You are on the list.
We will email your free MQB brief shortly. MQB is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.