Richard-Allan Medical Ind., Inc.: FDA clearances and approvals
Richard-Allan Medical Ind., Inc. has 33 FDA 510(k) clearances (first 1977, latest 1994), across 23 product codes in 5 review panels. Median 510(k) review time: 34 days.
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 |
|---|---|---|---|
| KEM | Agent, Clearing | 5 | 5 |
| MMK | Container, Sharps | 3 | 3 |
| PPM | General Purpose Reagent | 3 | 3 |
| FZP | Clip, Implantable | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| FTY | Tape, Measuring, Rulers And Calipers | 1 | 1 |
| FZQ | Clip, Removable (Skin) | 1 | 1 |
| FZZ | Marker, Skin | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GES | Blade, Scalpel | 1 | 1 |
Plus 13 more product codes.
Review panels
- Pathology (16)
- General and Plastic Surgery (11)
- General Hospital (3)
- Obstetrics and Gynecology (1)
- Ophthalmic (1)
Most recent Richard-Allan Medical Ind., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931879 | REFLEX HTR | GCJ | 1994-03-24 | 344 |
| K924200 | REFLEX(R) ESC | KNF | 1994-02-22 | 551 |
| K926297 | REFLEX ESI | GEI | 1993-10-15 | 305 |
| K924761 | STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD | GCJ | 1993-04-20 | 209 |
| K900566 | RICHARD-ALLAN VESSEL LOOPS | KDC | 1990-05-03 | 85 |
| K896262 | TITANIUM LIGATING CLIPS | HBT | 1990-01-02 | 64 |
| K890314 | PROTECTOR (SURGICAL INSTRUMENT) | MMK | 1989-02-27 | 35 |
| K873309 | REFLEX(TM) CA-T CLIP APPLIER | FZP | 1987-11-27 | 101 |
| K862404 | REFLEX(TM) CLIP APPLIER | FZP | 1986-07-23 | 28 |
| K862223 | MICRO THIN* PARAFFIN | KEO | 1986-06-17 | 6 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Richard-Allan Medical Ind., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Richard-Allan Medical Ind., Inc. have?
Richard-Allan Medical Ind., Inc. has 33 FDA 510(k) clearances (first 1977, latest 1994), across 23 product codes in 5 review panels.
How long does FDA take to clear Richard-Allan Medical Ind., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Richard-Allan Medical Ind., Inc.'s cleared 510(k)s is 34 days.
What devices does Richard-Allan Medical Ind., Inc. make?
Its most frequent FDA product codes are KEM (Agent, Clearing, 5); MMK (Container, Sharps, 3); PPM (General Purpose Reagent, 3).
Has Richard-Allan Medical Ind., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Richard-Allan Medical Ind., Inc. Related entities may recall under other names.
Next steps
- See all 33 Richard-Allan Medical Ind., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KEM, Richard-Allan Medical Ind., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.