Kmn Products, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Kmn Products, Inc.” (first 1982, latest 1982), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 34 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JIT | Calibrator, Secondary | 7 | 7 |
| JIX | Calibrator, Multi-Analyte Mixture | 5 | 5 |
Review panels
- Clinical Chemistry (12)
Most recent Kmn Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823044 | KM-KAL L3 | JIX | 1982-12-09 | 55 |
| K823025 | KM - KAL 2 | JIT | 1982-11-16 | 34 |
| K823024 | KM - KAL 1 | JIT | 1982-11-16 | 34 |
| K823023 | KM-KAL L6 | JIT | 1982-11-16 | 34 |
| K823022 | KM-KAL 6 | JIT | 1982-11-16 | 34 |
| K823021 | KM - KAL 5 | JIT | 1982-11-16 | 34 |
| K823020 | KM-KAL 4 | JIT | 1982-11-16 | 34 |
| K823019 | KM-KAL 3 | JIT | 1982-11-16 | 34 |
| K823046 | KM-KAL L5 | JIX | 1982-11-05 | 21 |
| K823045 | KM-KAL L4 | JIX | 1982-11-05 | 21 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kmn Products, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kmn Products, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Kmn Products, Inc.” (first 1982, latest 1982), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kmn Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kmn Products, Inc. is 34 days.
Which FDA product codes appear under Kmn Products, Inc.?
The most frequent FDA product codes under this applicant name are JIT (Calibrator, Secondary, 7); JIX (Calibrator, Multi-Analyte Mixture, 5).
Next steps
- See all 12 Kmn Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIT, Kmn Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.