Pymah Corp.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Pymah Corp.” (first 1988, latest 1996), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| DXQ | Blood Pressure Cuff | 5 | 5 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 5 | 5 |
| FRC | Indicator, Biological Sterilization Process | 4 | 4 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| FQZ | Thermometer, Clinical Color Change | 1 | 1 |
| MED | Sterilant, Medical Devices | 1 | 1 |
Review panels
- General Hospital (11)
- Cardiovascular (6)
Most recent Pymah Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952995 | ATI ETHYLENE OXIDE STERILIZATION INDICATOR | JOJ | 1996-02-22 | 239 |
| K952408 | ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION | JOJ | 1995-07-06 | 45 |
| K951063 | ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION | JOJ | 1995-05-10 | 63 |
| K934874 | STERIGAGE EO 100% | JOJ | 1995-04-18 | 553 |
| K943081 | TRIMLINE 2000 | DXN | 1995-01-27 | 213 |
| K925745 | ATI(R) DISP BIOLOGICAL-PLUS TEST PACK | FRC | 1994-02-01 | 445 |
| K925496 | ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK | FRC | 1994-02-01 | 459 |
| K934180 | SLIMLINE 3000 | DXQ | 1993-11-24 | 89 |
| K924681 | GLUTARALDEHYDE MONITORS | JOJ | 1993-11-17 | 427 |
| K925744 | TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF | DXQ | 1993-07-30 | 259 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pymah Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pymah Corp., Ati Div. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pymah Corp.?
FDA lists 17 510(k) clearances under the applicant name “Pymah Corp.” (first 1988, latest 1996), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pymah Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pymah Corp. is 89 days.
Which FDA product codes appear under Pymah Corp.?
The most frequent FDA product codes under this applicant name are DXQ (Blood Pressure Cuff, 5); JOJ (Indicator, Physical/Chemical Sterilization Process, 5); FRC (Indicator, Biological Sterilization Process, 4).
Next steps
- See all 17 Pymah Corp. clearances with predicates and recalls
- Run predicate analysis for product code DXQ, Pymah Corp.'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.