Product code JPK: 510(k) clearances and predicates
Product code JPK covers XN CHECK BF. FDA lists 192 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
192 clearances on file under product code JPK. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest JPK clearances in the FDA index, with applicant and decision date:
- K160590, XN CHECK, applicant Streck, decided 2016-12-22. FDA record
- K160586, XN-L CHECK, applicant Streck, decided 2016-12-22. FDA record
- K160588, XN CHECK BF, applicant Streck, decided 2016-12-22. FDA record
- K160606, BC-5D Hematology Control, applicant R&D Systems, Inc., decided 2016-09-01. FDA record
- K141964, XN CHECK, applicant Streck, decided 2014-12-05. FDA record
- K141957, XN CHECK BF, applicant Streck, decided 2014-12-05. FDA record
- K130962, R&D 5D RETIC HEMATOLOGY CONTROL, applicant R&D Systems, Inc., decided 2013-07-24. FDA record
- K120744, XN CHECK BF, applicant Streck, decided 2012-10-19. 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 XN CHECK, XN-L CHECK. Watch new JPK 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 JPK?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JPK clearances include XN CHECK BF.
How many 510(k) clearances use product code JPK?
192 at the time this page was generated, from openFDA records.
How do I find a predicate device under JPK?
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 JPK clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.