Pyng Medical Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pyng Medical Corp.” (first 1997, latest 2013), across 1 product code in 1 review panel. Median 510(k) review time under this name: 120 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 | 1 | 120 |
| 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Pyng Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130487 | FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE | FMI | 2013-06-25 | 120 |
| K100124 | FASTX STERNAL INTRAOSSEOUS DEVICE | FMI | 2010-08-31 | 224 |
| K080865 | FAST1 INTRAOSSEOUS INFUSION SYSTEM | FMI | 2008-04-24 | 27 |
| K072487 | FAST1 INTRAOSSEOUS INFUSION SYSTEM | FMI | 2008-02-13 | 162 |
| K970380 | F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM | FMI | 1997-04-25 | 81 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2015-08-31.
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 Pyng Medical Corp.?
FDA lists 5 510(k) clearances under the applicant name “Pyng Medical Corp.” (first 1997, latest 2013), across 1 product code 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 Pyng Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pyng Medical Corp. is 120 days.
Which FDA product codes appear under Pyng Medical Corp.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 5).
Next steps
- See all 5 Pyng Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Pyng 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, 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.