Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
J. Sklar Mfg. Co., Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
96 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K843693 | JACOBS HIGH VACUUM SUCTION UNIT 05-2570 | J. Sklar Mfg. Co., Inc. | 1984-10-31 | 42 | 0 |
| K842112 | TISCHLER CERVICAL BIOPSY PUNCH FORCEPS | J. Sklar Mfg. Co., Inc. | 1984-07-03 | 35 | 0 |
| K842111 | KOGAN ENDOSPECULUM 9-1/2 | J. Sklar Mfg. Co., Inc. | 1984-06-19 | 21 | 0 |
| K822448 | SCISSORS, VARIOUS | J. Sklar Mfg. Co., Inc. | 1982-09-14 | 29 | 0 |
| K802458 | KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 | J. Sklar Mfg. Co., Inc. | 1981-01-12 | 96 | 1 |
| K802457 | KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610 | J. Sklar Mfg. Co., Inc. | 1981-01-12 | 96 | 0 |
| K801273 | MAGILL CATHETER INTRO. FORCEPS | J. Sklar Mfg. Co., Inc. | 1980-07-28 | 60 | 1 |
| K800441 | RUDD-CLINIC HEMORRHOIDAL FORCEPS | J. Sklar Mfg. Co., Inc. | 1980-04-08 | 40 | 0 |
| K790577 | HEMORRHOIDAL LIGATOR | J. Sklar Mfg. Co., Inc. | 1979-04-23 | 26 | 0 |
| K772229 | MINICLAMPS, STABILIZ., FALLOPIAN TUBE | J. Sklar Mfg. Co., Inc. | 1978-01-03 | 28 | 5 |
| K772230 | CANNULA, PERFUSION, FALLOPIAN TUBE | J. Sklar Mfg. Co., Inc. | 1978-01-03 | 28 | 0 |
| K771806 | THOREK SCISSORS 7 1/4 & 10 | J. Sklar Mfg. Co., Inc. | 1977-10-04 | 11 | 0 |
| K771344 | GUSBERG HYSTERECTOMY CLAMP | J. Sklar Mfg. Co., Inc. | 1977-07-27 | 14 | 0 |
| K761334 | MARCUSE TUBE CLAMPING FORCEPS, STRAIGHT | J. Sklar Mfg. Co., Inc. | 1977-02-24 | 59 | 0 |
| K770040 | SCISSORS, STRABIMUS, 4 STRAIGHT | J. Sklar Mfg. Co., Inc. | 1977-01-14 | 4 | 0 |
| K770041 | SCISSORS, STRABISMUS, 4 CURVED | J. Sklar Mfg. Co., Inc. | 1977-01-14 | 4 | 0 |
| K770019 | SCISSORS, IRIS | J. Sklar Mfg. Co., Inc. | 1977-01-12 | 7 | 0 |
| K761338 | LEFF STETHOSCOPE FOR FETAL HEART | J. Sklar Mfg. Co., Inc. | 1977-01-12 | 16 | 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