Ritmed, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Ritmed, Inc.” (first 1983, latest 1984), across 11 product codes in 5 review panels. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 10 | 10 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 2 | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
| FQA | Scale, Surgical Sponge | 1 | 1 |
| FWZ | Operating Room Accessories Table Tray | 1 | 1 |
| GED | Brush, Dermabrasion, Manual | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GTC | Antisera, All Types, Klebsiella Spp. | 1 | 1 |
| HOZ | Sponge, Ophthalmic | 1 | 1 |
| LYA | Splint, Intranasal Septal | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (15)
- General Hospital (4)
- Ear, Nose and Throat (1)
- Microbiology (1)
- Ophthalmic (1)
Most recent Ritmed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833626 | FLORET FOAM PREP SPONGE | GDY | 1984-02-17 | 126 |
| K832874 | ISOVIS WOUND PROTECTOR | KKX | 1983-09-26 | 34 |
| K830270 | ISOVIS WOUND PROTECTOR | KKX | 1983-06-24 | 150 |
| K830268 | FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMIN | EFQ | 1983-06-08 | 134 |
| K830267 | FLORET SPECIAL GAUZE SPONGES | EFQ | 1983-06-08 | 134 |
| K830266 | FLORET KITTNER OR K DISSECTOR | EFQ | 1983-06-08 | 134 |
| K830261 | FLORET STRUNG GAUZE SPONGES | EFQ | 1983-06-08 | 134 |
| K830272 | PROTET HOLDERS-BLOCKS & ROLL | FWZ | 1983-06-03 | 129 |
| K830264 | FLORET TONSIL & ADENOID SPONGES | EFQ | 1983-06-03 | 129 |
| K830271 | LAPET & LAPWALL LAPAROTOMY SPONGES | EFQ | 1983-06-02 | 128 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ritmed, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ritmed, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Ritmed, Inc.” (first 1983, latest 1984), across 11 product codes in 5 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 Ritmed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ritmed, Inc. is 88 days.
Which FDA product codes appear under Ritmed, Inc.?
The most frequent FDA product codes under this applicant name are EFQ (Gauze/Sponge, Internal, 10); GDY (Gauze/Sponge, Internal, X-Ray Detectable, 2); KKX (Drape, Surgical, Antimicrobial, 2).
Next steps
- See all 22 Ritmed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Ritmed, 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, 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.