Oscor, Inc.: FDA filings under this applicant name
FDA lists 49 510(k) clearances under the applicant name “Oscor, Inc.” (first 1979, latest 2021), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 94 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 | 4 | 79 |
| 2013 | 1 | 149 |
| 2014 | 4 | 188 |
| 2015 | 2 | 87 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 93 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Oscor, Inc. took a median 93 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | 20 | 20 |
| DYB | Introducer, Catheter | 13 | 13 |
| DTD | Pacemaker Lead Adaptor | 4 | 4 |
| LDF | Electrode, Pacemaker, Temporary | 4 | 4 |
| DRC | Trocar | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DTE | Pulse-Generator, Pacemaker, External | 1 | 1 |
| DTG | Magnet, Test, Pacemaker | 1 | 1 |
| DYG | Catheter, Flow Directed | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (48)
- Physical Medicine (1)
Most recent Oscor, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210627 | Breezeway II | DYB | 2021-06-03 | 93 |
| K151951 | Destino Reach | DYB | 2015-09-22 | 69 |
| K143463 | IS4/DF4 Port Plug | DTD | 2015-03-19 | 105 |
| K140917 | INTRODUCER, MODEL ADELANTE MAGNUM | DYB | 2014-07-09 | 90 |
| K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH | DYB | 2014-04-17 | 58 |
| K130633 | INTRODUCER SETS, MODEL ADELANTE RADIAL | DYB | 2014-02-13 | 339 |
| K130843 | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE | DRC | 2014-01-08 | 287 |
| K130104 | GUIDEWIRE, PURSUER SERIES | DQX | 2013-06-13 | 149 |
| K122960 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | DYB | 2012-12-13 | 79 |
| K122958 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | DYB | 2012-12-13 | 79 |
39 earlier clearances. See the full list in Caduvo.
Recalls
42 product recalls in 10 recall events; 4 initiated in the last five years. Most recent: 2026-06-10.
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.
- Oscor Medical Corp. (31 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oscor, Inc.?
FDA lists 49 510(k) clearances under the applicant name “Oscor, Inc.” (first 1979, latest 2021), across 11 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 Oscor, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oscor, Inc. is 94 days.
Which FDA product codes appear under Oscor, Inc.?
The most frequent FDA product codes under this applicant name are DTB (Permanent Pacemaker Electrode, 20); DYB (Introducer, Catheter, 13); DTD (Pacemaker Lead Adaptor, 4).
Next steps
- See all 49 Oscor, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTB, Oscor, 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 (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.