Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Richard Hamer Assoc., Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
130 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962439 | DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) | Richard Hamer Assoc., Inc. | 1996-09-03 | 71 | 0 |
| K951325 | COMFEEL PLUS PRESSURE RELIEF DRESSING | Richard Hamer Assoc., Inc. | 1995-07-31 | 130 | 0 |
| K950934 | MPM HYDROGEL DRESSING | Richard Hamer Assoc., Inc. | 1995-05-16 | 76 | 0 |
| K951327 | COMFEEL PLUS CONTOUR DRESSING | Richard Hamer Assoc., Inc. | 1995-04-28 | 36 | 0 |
| K942283 | COMFEEL PLUS TRANSPARENT DRESSING | Richard Hamer Assoc., Inc. | 1994-07-29 | 79 | 0 |
| K942573 | COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH | Richard Hamer Assoc., Inc. | 1994-07-18 | 48 | 0 |
| K941263 | COMFEEL PLUS WOUND DRESSING | Richard Hamer Assoc., Inc. | 1994-05-10 | 55 | 0 |
| K934839 | MESALT STERILE DRESSING | Richard Hamer Assoc., Inc. | 1993-12-22 | 75 | 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