Osypka Medical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Osypka Medical, Inc.” (first 2002, latest 2013), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 62 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 | 111 |
| 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 |
|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | 4 | 4 |
| DSB | Plethysmograph, Impedance | 3 | 3 |
Review panels
- Cardiovascular (7)
Most recent Osypka Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123916 | PSA SERIES | DTE | 2013-04-09 | 111 |
| K082242 | ICON, MODEL C3 | DSB | 2008-10-08 | 62 |
| K081035 | AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 | DSB | 2008-05-30 | 49 |
| K070985 | AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC | DSB | 2008-02-01 | 301 |
| K033130 | PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR | DTE | 2003-10-31 | 31 |
| K022939 | OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES | DTE | 2002-10-03 | 29 |
| K020896 | OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE | DTE | 2002-06-14 | 87 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-06-30.
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.
- Osypka AG (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Osypka Medical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Osypka Medical, Inc.” (first 2002, latest 2013), across 2 product codes 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 Osypka Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osypka Medical, Inc. is 62 days.
Which FDA product codes appear under Osypka Medical, Inc.?
The most frequent FDA product codes under this applicant name are DTE (Pulse-Generator, Pacemaker, External, 4); DSB (Plethysmograph, Impedance, 3).
Next steps
- See all 7 Osypka Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTE, Osypka Medical, 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.