Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Invitrocare, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
224 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023222 | ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12 | Invitrocare, Inc. | 2002-12-26 | 90 | 0 |
| K003751 | HYALURONIDASE REAGENT, MODEL CAT#2212 | Invitrocare, Inc. | 2001-01-17 | 43 | 0 |
| K001967 | PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210 | Invitrocare, Inc. | 2000-08-14 | 47 | 0 |
| K001113 | IVC THREE BLASTOCYST MEDIUM, CAT # 2007 | Invitrocare, Inc. | 2000-06-13 | 68 | 0 |
| K000989 | SPERM WASH MEDIUM, CAT# 2003/2005 | Invitrocare, Inc. | 2000-06-08 | 72 | 0 |
| K000937 | IVC TWO MEDIUM | Invitrocare, Inc. | 2000-05-25 | 63 | 0 |
| K993484 | Q-HTF, CAT# 2001 | Invitrocare, Inc. | 2000-05-25 | 224 | 0 |
| K000938 | IVC ONE MEDIUM | Invitrocare, Inc. | 2000-05-25 | 63 | 0 |
| K000939 | HTF-HEPES | Invitrocare, Inc. | 2000-05-04 | 42 | 0 |
| K000940 | HUMAN SERUM ALBUMIN (HSA) | Invitrocare, Inc. | 2000-05-04 | 42 | 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