Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LRD · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
140 daysmedian FDA review time
472 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984345 | AROMAPATCH | Envis, Inc. | 1999-03-19 | 105 | 0 |
| K932522 | AMSCO STERILE RECOVERIES SURGICAL PACKS | Amsco Sterile Recoveries, Inc. | 1994-09-09 | 472 | 0 |
| K942789 | MISTASSIST | The Merlin Corp. | 1994-08-12 | 59 | 0 |
| K940133 | THE EXPANDACELL EAR PACK | Denver Splint Co. | 1994-05-23 | 140 | 0 |
| K925022 | SURGICAL TRAY (STERILE) | Customed, Inc. | 1993-04-26 | 214 | 0 |
| K920842 | AEROSOL DELIVERY SYSTEMS | Hospitak, Inc. | 1992-05-15 | 81 | 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