Penn Medical Devices, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Penn Medical Devices, Inc.” (first 1986, latest 1987), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| BTQ | Airway, Nasopharyngeal | 1 | 1 |
| EZN | Dilator, Catheter, Ureteral | 1 | 1 |
| FAD | Stent, Ureteral | 1 | 1 |
| FCL | Forceps, Biopsy, Non-Electric | 1 | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| KOE | Dilator, Urethral | 1 | 1 |
| ODC | Endoscope Channel Accessory | 1 | 1 |
Review panels
Most recent Penn Medical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873949 | RORERTAZZI NASOPHARYNGEAL AIRWAY | BTQ | 1987-10-20 | 22 |
| K873177 | DEVINE (SUPRAPUBIC SOUND AND GUIDE) | KOE | 1987-10-14 | 63 |
| K873176 | HUFFMAN BIOPSY UNIT | FCL | 1987-10-14 | 63 |
| K873178 | URETERAL BULB DILATORS | EZN | 1987-09-30 | 49 |
| K871667 | URETERAL STENT | FAD | 1987-06-10 | 43 |
| K870508 | GASTROINTESTINAL TUBE | KNT | 1987-05-11 | 95 |
| K862729 | PENN 3-RING HANDLE | FFL | 1986-10-24 | 98 |
| K862107 | PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR | ODC | 1986-09-11 | 100 |
Recalls
openFDA lists no recalls under a recalling firm named Penn Medical Devices, 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 Penn Medical Devices, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Penn Medical Devices, Inc.” (first 1986, latest 1987), across 8 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 Penn Medical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Penn Medical Devices, Inc. is 63 days.
Which FDA product codes appear under Penn Medical Devices, Inc.?
The most frequent FDA product codes under this applicant name are BTQ (Airway, Nasopharyngeal, 1); EZN (Dilator, Catheter, Ureteral, 1); FAD (Stent, Ureteral, 1).
Next steps
- See all 8 Penn Medical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTQ, Penn Medical Devices, 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.