Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MLS · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
195 daysmedian FDA review time
350 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961993 | BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) | Devon Industries, Inc. | 1996-07-03 | 43 | 0 |
| K960243 | CPR C-SECTION DELIVERY PACK | Custom Pack Reliability | 1996-05-23 | 128 | 0 |
| K940518 | C-SECTION TRAY | Cush Medical Products | 1994-08-18 | 195 | 0 |
| K932216 | C-SECTION, LABOR & DELIVERY TRAYS (PACKS) | Associated Medical Products Co. | 1994-04-19 | 347 | 0 |
| K936120 | LABOR AND DELIVERY TRAY | Cush Medical Products | 1994-03-30 | 97 | 0 |
| K931722 | CARAPACE LABOR AND DELIVERY SETS | Carapace, Inc. | 1994-03-23 | 350 | 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