Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
HDD · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
116 daysmedian FDA review time
230 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950889 | ADEL 5000 | Stryker Corp. | 1995-10-16 | 230 | 4 |
| K914309 | THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES | Hill-Rom, Inc. | 1992-04-20 | 208 | 0 |
| K875123 | ORCEPAD | Alton Dean Medical, Inc. | 1988-06-21 | 189 | 0 |
| K874610 | ADEL MODEL 2100 BIRTHING BED | Adel Medical , Ltd. | 1988-01-21 | 73 | 0 |
| K810886 | ADEL MEDICAL BIRTHING BED, #LD-500 | Adel Medical , Ltd. | 1981-04-23 | 22 | 0 |
| K771942 | TILT 10, CATALOG #S-2600 | Affiliated Hospital Products, Inc. | 1977-10-27 | 10 | 0 |
| K770438 | CART, PROCEDURES | I E Industries | 1977-07-01 | 116 | 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