Richard Hamer Assoc., Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Richard Hamer Assoc., Inc.” (first 1993, latest 1996), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 73 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KMF | Bandage, Liquid | 4 | 4 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 2 | 2 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
| FMP | Protector, Skin Pressure | 1 | 1 |
Review panels
Most recent Richard Hamer Assoc., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962439 | DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) | MGQ | 1996-09-03 | 71 |
| K951325 | COMFEEL PLUS PRESSURE RELIEF DRESSING | FMP | 1995-07-31 | 130 |
| K950934 | MPM HYDROGEL DRESSING | MGQ | 1995-05-16 | 76 |
| K951327 | COMFEEL PLUS CONTOUR DRESSING | KMF | 1995-04-28 | 36 |
| K942283 | COMFEEL PLUS TRANSPARENT DRESSING | KMF | 1994-07-29 | 79 |
| K942573 | COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH | FED | 1994-07-18 | 48 |
| K941263 | COMFEEL PLUS WOUND DRESSING | KMF | 1994-05-10 | 55 |
| K934839 | MESALT STERILE DRESSING | KMF | 1993-12-22 | 75 |
Recalls
openFDA lists no recalls under a recalling firm named Richard Hamer Assoc., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Richard Wolf Medical Instruments Corp. (153 510(k)s)
- Richard'S Medical Equip., Inc. (48 510(k)s)
- Richard-Allan Medical Ind., Inc. (33 510(k)s)
- Richard-Allan Medical (8 510(k)s)
- Richard F. Kronner, M.D. (3 510(k)s)
- Richard James, Inc. (2 510(k)s)
- Richard D. Spradlin (1 510(k)s)
- Richard G. Deniro (1 510(k)s)
- Richard G. Lindsay (1 510(k)s)
- Richard J. Turner Assoc. (1 510(k)s)
- Richard R. Anthony, M.D. (1 510(k)s)
- Richard Scott Elliott (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Richard Hamer Assoc., Inc.?
FDA lists 8 510(k) clearances under the applicant name “Richard Hamer Assoc., Inc.” (first 1993, latest 1996), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Richard Hamer Assoc., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Richard Hamer Assoc., Inc. is 73 days.
Which FDA product codes appear under Richard Hamer Assoc., Inc.?
The most frequent FDA product codes under this applicant name are KMF (Bandage, Liquid, 4); MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, 2); FED (Endoscopic Access Overtube, Gastroenterology-Urology, 1).
Next steps
- See all 8 Richard Hamer Assoc., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KMF, Richard Hamer Assoc., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.