Pa Medical Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pa Medical Corp.” (first 1985, latest 1991), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 64 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 | 1 | 1 |
| HED | Douche Apparatus, Vaginal, Therapeutic | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
| KZD | Infusor, Pressure, For I.V. Bags | 1 | 1 |
Review panels
Most recent Pa Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910903 | INFLATE-A-CUFF #7014 | DXQ | 1991-05-08 | 64 |
| K871449 | ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG | KPE | 1987-06-17 | 65 |
| K860084 | PRESSURE INFUSOR #1900 | KZD | 1986-03-18 | 68 |
| K854595 | P.A. MEDICAL VAGINAL IRRIGATION SET #1130 | HED | 1986-01-13 | 56 |
| K853309 | P.A. ENTERAL FEEDING BAG 1100 | KNT | 1985-08-27 | 20 |
Recalls
openFDA lists no recalls under a recalling firm named Pa Medical 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Pa Medical Corp.?
FDA lists 5 510(k) clearances under the applicant name “Pa Medical Corp.” (first 1985, latest 1991), across 5 product codes in 4 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 Pa Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pa Medical Corp. is 64 days.
Which FDA product codes appear under Pa Medical Corp.?
The most frequent FDA product codes under this applicant name are DXQ (Blood Pressure Cuff, 1); HED (Douche Apparatus, Vaginal, Therapeutic, 1); KNT (Tubes, Gastrointestinal (And Accessories), 1).
Next steps
- See all 5 Pa Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code DXQ, Pa Medical 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.