Product code KIT: 510(k) clearances and predicates
Product code KIT covers AMNIO-GROW TM. FDA lists 367 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
367 clearances on file under product code KIT. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest KIT clearances in the FDA index, with applicant and decision date:
- K892938, AMNIO-GROW TM, applicant Inovar Biologicals, Inc., decided 1989-05-22. FDA record
- K890700, MELANOCYTE GROWTH MEDIUM (MGM), applicant Clonetics Corp., decided 1989-02-24. FDA record
- K890701, ENDOTHELIAL GROWTH MEDIUM (EGM), applicant Clonetics Corp., decided 1989-02-24. FDA record
- K890482, ABC, ABC-1X, ABC(TM), applicant Cell Ent., Inc., decided 1989-02-10. FDA record
- K884654, ALPHACALF SERUM, applicant Hyclone Laboratories, Inc., decided 1988-11-30. FDA record
- K884572, RPMI-1640 HYBRI-MAX, PROD. NO. R5382, applicant Sigma Chemical Co., decided 1988-11-22. FDA record
- K884574, DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785, applicant Sigma Chemical Co., decided 1988-11-22. FDA record
- K884573, HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891, applicant Sigma Chemical Co., decided 1988-11-22. 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 MELANOCYTE GROWTH MEDIUM (MGM), ENDOTHELIAL GROWTH MEDIUM (EGM). Watch new KIT 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 KIT?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KIT clearances include AMNIO-GROW TM.
How many 510(k) clearances use product code KIT?
367 at the time this page was generated, from openFDA records.
How do I find a predicate device under KIT?
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 KIT 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.