Product code JAQ: 510(k) clearances and predicates
Product code JAQ covers LumenCare Azure. FDA lists 208 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
208 clearances on file under product code JAQ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 10 |
| 2025 | 6 |
| 2026 so far | 2 |
Recent clearances
Newest JAQ clearances in the FDA index, with applicant and decision date:
- K262383, LumenCare Azure, applicant Nucletron B.V., decided 2026-07-24. FDA record
- K252717, MAASTRO Rectal Applicator Set, applicant Varian Medical Systems, decided 2026-05-20. FDA record
- K251037, Rectal Applicator, applicant Nucletron B.V., decided 2025-12-19. FDA record
- K252884, Guided Aarhus Applicator Set, applicant Varian Medical Systems, decided 2025-11-19. FDA record
- K250299, CT/ MR Tandem and Ovoid Set, applicant Varian Medical Systems, Inc., decided 2025-05-09. FDA record
- K250289, Intracavitary/Interstitial System, applicant Varian Medical Systems, decided 2025-04-25. FDA record
- K243939, Titanium Flexible Geometry FSD Applicator Set (GM11013400), applicant Varian Medical Systems, Inc., decided 2025-03-03. FDA record
- K241764, Mould Probe MR Safe, applicant Varian Medical Systems, Inc., decided 2025-01-10. 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 MAASTRO Rectal Applicator Set, Rectal Applicator. Watch new JAQ 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 JAQ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JAQ clearances include LumenCare Azure.
How many 510(k) clearances use product code JAQ?
208 at the time this page was generated, from openFDA records.
How do I find a predicate device under JAQ?
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 JAQ clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.