Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Simpson/Basye, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
38 daysmedian FDA review time
105 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K926179 | SEDLACEK HANDLE | Simpson/Basye, Inc. | 1994-03-25 | 472 | 0 |
| K891352 | MARLOW ANAL SPECULUM | Simpson/Basye, Inc. | 1989-06-23 | 105 | 0 |
| K891351 | NEWPORT LATERAL VAGINAL RETRACTOR | Simpson/Basye, Inc. | 1989-05-11 | 62 | 0 |
| K891349 | CAMPION CERVICAL HOOK | Simpson/Basye, Inc. | 1989-03-29 | 19 | 0 |
| K891350 | NEWPORT CERVICAL MANIPULATOR | Simpson/Basye, Inc. | 1989-03-29 | 19 | 0 |
| K891347 | REID ENDOCERVICAL SPREADER | Simpson/Basye, Inc. | 1989-03-29 | 19 | 0 |
| K891348 | CAMPION LASER FORCEPS | Simpson/Basye, Inc. | 1989-03-22 | 12 | 0 |
| K870276 | HEATED INSTRUMENT BATH | Simpson/Basye, Inc. | 1987-05-07 | 100 | 0 |
| K862717 | HAND MIRROR (ENDOSCOPE) | Simpson/Basye, Inc. | 1986-07-30 | 13 | 0 |
| K862629 | SURGICAL LASER ACCESSORIES (SLA) CASE | Simpson/Basye, Inc. | 1986-07-17 | 7 | 0 |
| K790923 | MI-MARK ENDOCERVICAL SAMPLING SET | Simpson/Basye, Inc. | 1979-06-22 | 38 | 0 |
| K772298 | SEXUAL ASSAULT FORENCIC EVIDENCE KIT | Simpson/Basye, Inc. | 1978-03-02 | 79 | 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