Ritter Co.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Ritter Co.” (first 1976, latest 1983), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 21 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| KLC | Chair, Dental, With Operative Unit | 2 | 2 |
| EAY | Light, Fiber Optic, Dental | 1 | 1 |
| EAZ | Light, Operating, Dental | 1 | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HAM | Apparatus, Electrosurgical | 1 | 1 |
Review panels
- Dental (6)
- Cardiovascular (2)
- General and Plastic Surgery (2)
Most recent Ritter Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K831245 | TAYLOR PRINTER/AUTO INFLAT-SPHYGMOMANO | DXN | 1983-10-19 | 184 |
| K832171 | SELF CHECK DIGITAL BLOOD PRESS. MONITOR | DXN | 1983-10-04 | 90 |
| K831976 | POWER OPTIC | EAY | 1983-08-12 | 53 |
| K823180 | SA-21 DENTAL UNIT | EIA | 1982-11-22 | 21 |
| K800084 | RITTER MODEL J DENTAL CHAIR | KLC | 1980-01-29 | 15 |
| K781101 | ELECTROSURGICAL UNIT 75 | GEI | 1978-07-17 | 14 |
| K780293 | ELECTROSURGICAL UNIT | HAM | 1978-03-14 | 21 |
| K772300 | DENTAL CHAIR, VANGUARD | KLC | 1978-01-03 | 20 |
| K760929 | ACCUTORQ II | EFB | 1976-11-19 | 21 |
| K760707 | RITTER STARLIGHT DENTAL OPERATING LIGHT | EAZ | 1976-10-05 | 12 |
Recalls
openFDA lists no recalls under a recalling firm named Ritter Co..
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.
- Ritter Implants GmbH & Co. KG (2 510(k)s)
- Ritter Concept GmbH (1 510(k)s)
- Ritter Implants GmbH CO KG (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ritter Co.?
FDA lists 10 510(k) clearances under the applicant name “Ritter Co.” (first 1976, latest 1983), across 8 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 Ritter Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ritter Co. is 21 days.
Which FDA product codes appear under Ritter Co.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); KLC (Chair, Dental, With Operative Unit, 2); EAY (Light, Fiber Optic, Dental, 1).
Next steps
- See all 10 Ritter Co. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Ritter Co.'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.