Richard-Allan Medical: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Richard-Allan Medical” (first 1991, latest 1994), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 112 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| GAG | Stapler, Surgical | 1 | 1 |
| GEF | Applier, Staple, Surgical, | 1 | 1 |
| HBT | Applier, Hemostatic Clip | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Review panels
Most recent Richard-Allan Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942207 | REFLEX INS INSUFFLATION NEEDLE | HIF | 1994-05-27 | 22 |
| K935105 | REFLEX ESP WITH FINGER SWITCHES | GEI | 1994-02-22 | 123 |
| K933508 | REFLEX SDD SURGICAL STAPLER | GEF | 1993-11-23 | 126 |
| K933901 | REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) | GAG | 1993-11-19 | 101 |
| K924881 | REFLEX(R) ESP | GEI | 1993-07-23 | 298 |
| K924929 | REFLEX(R) ECA | HBT | 1993-07-21 | 294 |
| K905701 | RICHARD-ALLAN SHEET CLIP | KKX | 1991-02-19 | 61 |
| K905682 | RICHARD-ALLAN CLAMP COVERS | FSM | 1991-02-19 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named Richard-Allan Medical.
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-Allan Medical Ind., Inc. (33 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Richard-Allan Medical?
FDA lists 8 510(k) clearances under the applicant name “Richard-Allan Medical” (first 1991, latest 1994), across 7 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-Allan Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Richard-Allan Medical is 112 days.
Which FDA product codes appear under Richard-Allan Medical?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); FSM (Tray, Surgical, Instrument, 1); GAG (Stapler, Surgical, 1).
Next steps
- See all 8 Richard-Allan Medical clearances with predicates and recalls
- Run predicate analysis for product code GEI, Richard-Allan Medical'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.