Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Conception Technology, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
109 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030117 | ENHANCE SPERM FREEZE | Conception Technology, Inc. | 2003-03-20 | 66 | 0 |
| K030116 | ENHANCE-S PLUS H | Conception Technology, Inc. | 2003-02-12 | 30 | 0 |
| K991322 | ENHANCE-S PLUS | Conception Technology, Inc. | 1999-07-26 | 98 | 0 |
| K991104 | MICROTOOLS | Conception Technology, Inc. | 1999-07-19 | 109 | 0 |
| K973860 | OVULON MONITOR | Conception Technology, Inc. | 1998-01-07 | 90 | 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