Oscor Medical Corp.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Oscor Medical Corp.” (first 1985, latest 1997), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | 22 | 22 |
| LDF | Electrode, Pacemaker, Temporary | 4 | 4 |
| DTC | Analyzer, Pacemaker Generator Function | 1 | 1 |
| DTD | Pacemaker Lead Adaptor | 1 | 1 |
| DTE | Pulse-Generator, Pacemaker, External | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| LQR | Dislodger, Stone, Biliary | 1 | 1 |
Review panels
Most recent Oscor Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964107 | OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR | DTB | 1997-04-01 | 168 |
| K925168 | MISCELLANEOUS PACING LEAD | DTD | 1994-05-03 | 567 |
| K923621 | EXTERNAL DEMAND PACEMAKER | DTE | 1993-05-19 | 302 |
| K912867 | OSCOR MEDICAL CORP PERMANENT PACING LEAD | DTB | 1992-02-04 | 221 |
| K915008 | PERMANENT PACING PAD, MODIFICATION | DTB | 1992-01-27 | 84 |
| K915007 | PERMANENT PACING LEADS, MODIFICATION | DTB | 1992-01-27 | 84 |
| K913393 | IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION | DTB | 1991-09-23 | 77 |
| K913205 | OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF | DTB | 1991-09-23 | 77 |
| K913204 | MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION | DTB | 1991-09-23 | 77 |
| K913203 | IMPLANT PACING LEAD TINED #3390, MODIFICATION | DTB | 1991-09-23 | 77 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Oscor 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.
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, Inc. (49 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oscor Medical Corp.?
FDA lists 31 510(k) clearances under the applicant name “Oscor Medical Corp.” (first 1985, latest 1997), across 7 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 Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oscor Medical Corp. is 86 days.
Which FDA product codes appear under Oscor Medical Corp.?
The most frequent FDA product codes under this applicant name are DTB (Permanent Pacemaker Electrode, 22); LDF (Electrode, Pacemaker, Temporary, 4); DTC (Analyzer, Pacemaker Generator Function, 1).
Next steps
- See all 31 Oscor Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code DTB, Oscor 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.