Kermath Mfg. Corp.: FDA clearances and approvals
Kermath Mfg. Corp. has 5 FDA 510(k) clearances (first 1977, latest 1987), across 3 product codes in 1 review panel. Median 510(k) review time: 38 days.
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 |
|---|---|---|---|
| KPQ | System, Simulation, Radiation Therapy | 2 | 2 |
| KPR | System, X-Ray, Stationary | 2 | 2 |
| IZF | System, X-Ray, Tomographic | 1 | 1 |
Review panels
- Radiology (5)
Most recent Kermath Mfg. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870221 | T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING) | KPQ | 1987-05-12 | 111 |
| K812726 | KERMATH THERAPY SIMULATOR | KPQ | 1981-11-05 | 38 |
| K812332 | KERMATH L/C ARM | KPR | 1981-09-16 | 29 |
| K811215 | KERMATH RADIOGRAPHIC HEAD STAND | KPR | 1981-06-12 | 39 |
| K771549 | VERSATOME | IZF | 1977-08-25 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Kermath Mfg. Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Kermath Mfg. Corp. have?
Kermath Mfg. Corp. has 5 FDA 510(k) clearances (first 1977, latest 1987), across 3 product codes in 1 review panel.
How long does FDA take to clear Kermath Mfg. Corp.'s 510(k)s?
The median time from FDA receipt to decision across Kermath Mfg. Corp.'s cleared 510(k)s is 38 days.
What devices does Kermath Mfg. Corp. make?
Its most frequent FDA product codes are KPQ (System, Simulation, Radiation Therapy, 2); KPR (System, X-Ray, Stationary, 2); IZF (System, X-Ray, Tomographic, 1).
Has Kermath Mfg. Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kermath Mfg. Corp. Related entities may recall under other names.
Next steps
- See all 5 Kermath Mfg. Corp. clearances with predicates and recalls
- Run predicate analysis for product code KPQ, Kermath Mfg. Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.