Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Humagen Fertility Diagnostics, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
121 daysmedian FDA review time
1014 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012811 | BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS | Humagen Fertility Diagnostics, Inc. | 2002-02-11 | 173 | 0 |
| K000915 | PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MO | Humagen Fertility Diagnostics, Inc. | 2000-05-12 | 51 | 2 |
| K990847 | INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATI | Humagen Fertility Diagnostics, Inc. | 1999-07-14 | 121 | 0 |
| K990941 | NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MO | Humagen Fertility Diagnostics, Inc. | 1999-07-14 | 114 | 0 |
| K915229 | SEMEN ANALYSIS KIT | Humagen Fertility Diagnostics, Inc. | 1994-08-30 | 1014 | 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