Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oscor Medical Corp. — Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
198 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964107 | OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR | Oscor Medical Corp. | 1997-04-01 | 168 | 0 |
| K925168 | MISCELLANEOUS PACING LEAD | Oscor Medical Corp. | 1994-05-03 | 567 | 0 |
| K923621 | EXTERNAL DEMAND PACEMAKER | Oscor Medical Corp. | 1993-05-19 | 302 | 0 |
| K912867 | OSCOR MEDICAL CORP PERMANENT PACING LEAD | Oscor Medical Corp. | 1992-02-04 | 221 | 0 |
| K915008 | PERMANENT PACING PAD, MODIFICATION | Oscor Medical Corp. | 1992-01-27 | 84 | 0 |
| K915007 | PERMANENT PACING LEADS, MODIFICATION | Oscor Medical Corp. | 1992-01-27 | 84 | 0 |
| K913201 | PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION | Oscor Medical Corp. | 1991-09-23 | 77 | 0 |
| K913203 | IMPLANT PACING LEAD TINED #3390, MODIFICATION | Oscor Medical Corp. | 1991-09-23 | 77 | 0 |
| K913205 | OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF | Oscor Medical Corp. | 1991-09-23 | 77 | 0 |
| K913204 | MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION | Oscor Medical Corp. | 1991-09-23 | 77 | 0 |
| K913202 | IMPLANT PACING LEAD, TINED #3262, MODIFICATION | Oscor Medical Corp. | 1991-09-23 | 77 | 0 |
| K913393 | IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION | Oscor Medical Corp. | 1991-09-23 | 77 | 0 |
| K913158 | MODIFIED OSCOR PY PACING LEADS/MODIFICATION | Oscor Medical Corp. | 1991-09-23 | 77 | 0 |
| K905300 | PERMANENT PACING LEAD | Oscor Medical Corp. | 1991-05-07 | 161 | 0 |
| K905182 | OSCOR MEDICAL CORP. PERMANENT PACING PAD | Oscor Medical Corp. | 1991-05-07 | 169 | 0 |
| K884866 | TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 | Oscor Medical Corp. | 1989-03-22 | 121 | 1 |
| K890277 | HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT | Oscor Medical Corp. | 1989-03-10 | 51 | 0 |
| K882345 | PERMANENT PACING LEADS PYBJ SERIES | Oscor Medical Corp. | 1988-10-28 | 143 | 0 |
| K882462 | PERMANENT PACING LEAD MODEL RXBJ SERIES | Oscor Medical Corp. | 1988-10-28 | 135 | 0 |
| K882327 | PACER SENSING ANALYZER (PSA 100) | Oscor Medical Corp. | 1988-10-06 | 122 | 0 |
| K872971 | PERMANENT MYOCARDIAL LEADS MP SERIES | Oscor Medical Corp. | 1988-02-12 | 198 | 1 |
| K872972 | TEMPORARY PACEMAKER ELECTRODE | Oscor Medical Corp. | 1987-12-03 | 127 | 0 |
| K870034 | MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD | Oscor Medical Corp. | 1987-03-03 | 57 | 0 |
| K862949 | HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER | Oscor Medical Corp. | 1986-10-31 | 87 | 0 |
| K862966 | 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) | Oscor Medical Corp. | 1986-10-31 | 86 | 0 |
| K861493 | OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH | Oscor Medical Corp. | 1986-08-28 | 128 | 0 |
| K862330 | MODIFIED OSCOR PY PACING LEADS | Oscor Medical Corp. | 1986-08-08 | 50 | 0 |
| K861403 | TB SERIES BIPOLAR PACING LEADS | Oscor Medical Corp. | 1986-06-27 | 73 | 1 |
| K854128 | OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE | Oscor Medical Corp. | 1986-02-26 | 140 | 0 |
| K850623 | OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE | Oscor Medical Corp. | 1985-04-19 | 59 | 0 |
| K850622 | OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR | Oscor Medical Corp. | 1985-04-10 | 50 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda