Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dispomed, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
121 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K892748 | PATIENT EXAM GLOVES (MFG. AMMATEX) | Dispomed, Inc. | 1989-08-10 | 121 | 0 |
| K891054 | NON-STERILE GAUZE SPONGE | Dispomed, Inc. | 1989-05-01 | 63 | 0 |
| K891053 | DENTAL BIB | Dispomed, Inc. | 1989-04-12 | 44 | 0 |
| K891056 | SURGICAL CONE MASK | Dispomed, Inc. | 1989-04-12 | 44 | 0 |
| K891051 | SURGICAL FACE MASK-EAR LOOP | Dispomed, Inc. | 1989-04-12 | 44 | 0 |
| K891058 | DENTAL GOWN | Dispomed, Inc. | 1989-04-12 | 44 | 0 |
| K891052 | SPLASH GUARD GOGGLE | Dispomed, Inc. | 1989-04-12 | 44 | 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