Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ortho Pharmaceutical Corp. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
192 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955648 | K-Y PERSONAL LUBRICANT | Ortho Pharmaceutical Corp. | 1996-06-21 | 192 | 0 |
| K934516 | ADVANCE PREGNANCY TEST MODIFICATION | Ortho Pharmaceutical Corp. | 1994-02-24 | 160 | 0 |
| K914990 | ADVANCE(R) PREGNANCY TEST | Ortho Pharmaceutical Corp. | 1991-12-23 | 46 | 0 |
| K893488 | PULSATILE PUMP FOR GONADORELIN ACETATE | Ortho Pharmaceutical Corp. | 1989-10-31 | 180 | 0 |
| K881151 | MICROSCRAPE | Ortho Pharmaceutical Corp. | 1988-04-06 | 20 | 0 |
| K810581 | FACT* HOME PREGNANCY TEST | Ortho Pharmaceutical Corp. | 1981-03-17 | 14 | 0 |
| K800754 | NICKERSON'S MED. SELECTIVE CULTURE MEDIU | Ortho Pharmaceutical Corp. | 1980-04-29 | 25 | 0 |
| K792634 | CONCEPTROL/THIN PROPHYLACTICS | Ortho Pharmaceutical Corp. | 1980-01-16 | 28 | 0 |
| K790087 | LUBRICANT, OTRHO PERSONAL | Ortho Pharmaceutical Corp. | 1979-02-01 | 15 | 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