Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KHR · Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
90 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980783 | SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 | Irt Management Corp. | 1998-04-21 | 50 | 0 |
| K954068 | GENERAL HYGIENE KIT | Physician Industries, Inc. | 1995-11-08 | 70 | 0 |
| K953812 | GAUZE SPONGE | Remington Medical, Inc. | 1995-10-02 | 61 | 0 |
| K891054 | NON-STERILE GAUZE SPONGE | Dispomed, Inc. | 1989-05-01 | 63 | 0 |
| K891354 | ORTHODONTIC COTTON ROLL HOLDERS | American Orthodontics | 1989-04-17 | 38 | 0 |
| K890734 | DRY TIPS | Microcopy, Div. Neo-Flo, Inc. | 1989-03-10 | 25 | 0 |
| K870383 | ALGINATE WOOL FIBER | Adri | 1987-04-30 | 90 | 0 |
| K850988 | BOVO MOISTURE GUARD | E.H. Medical Co. | 1985-04-16 | 36 | 0 |
| K780400 | DEN-Z-ORB | Nice-Pak Products, Inc. | 1978-03-27 | 14 | 0 |
| K771908 | ISO-SHIELD SALIVA ABSORBERS | 3M Company | 1977-11-07 | 27 | 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