Rudolf Riester GmbH & Co. KG: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Rudolf Riester GmbH & Co. KG” (first 1993, latest 2000), across 9 product codes in 6 review panels. Median 510(k) review time under this name: 140 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 |
|---|---|---|---|
| ERA | Otoscope | 9 | 9 |
| DXQ | Blood Pressure Cuff | 8 | 8 |
| HLJ | Ophthalmoscope, Battery-Powered | 6 | 6 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| CCW | Laryngoscope, Rigid | 1 | 1 |
| EPY | Speculum, Ent | 1 | 1 |
| HKM | Retinoscope, Battery-Powered | 1 | 1 |
| HKY | Tonometer, Manual | 1 | 1 |
| KZF | Device, Medical Examination, Ac Powered | 1 | 1 |
Review panels
- Cardiovascular (10)
- Ear, Nose and Throat (9)
- Ophthalmic (8)
- Anesthesiology (1)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Rudolf Riester GmbH & Co. KG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002955 | EMPIRE N BLOOD PRESSURE MANOMETERS | DXQ | 2000-12-21 | 90 |
| K002954 | RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS | DXQ | 2000-12-21 | 90 |
| K972379 | PRECISA N | DXQ | 1997-09-24 | 90 |
| K972378 | SANAPHON N | DXQ | 1997-09-24 | 90 |
| K972377 | RI-MEGA | DXQ | 1997-09-24 | 90 |
| K972301 | BIG BEN SQUARE, BIG BEN ROUND | DXQ | 1997-09-17 | 90 |
| K964338 | RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT | HKM | 1997-01-09 | 70 |
| K950914 | RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V | HLJ | 1995-07-24 | 151 |
| K950913 | PERFECT, ENT SET, PRAKTIKANT, DE LUXE | ERA | 1995-05-12 | 78 |
| K945541 | SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE | HKY | 1995-05-08 | 179 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Rudolf Riester GmbH & Co. KG.
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.
- Rudolf Riester GmbH (3 510(k)s)
- Rudolf Medical GmbH + Co. KG (1 510(k)s)
- Rudolf Storz GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rudolf Riester GmbH & Co. KG?
FDA lists 30 510(k) clearances under the applicant name “Rudolf Riester GmbH & Co. KG” (first 1993, latest 2000), across 9 product codes in 6 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 Rudolf Riester GmbH & Co. KG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rudolf Riester GmbH & Co. KG is 140 days.
Which FDA product codes appear under Rudolf Riester GmbH & Co. KG?
The most frequent FDA product codes under this applicant name are ERA (Otoscope, 9); DXQ (Blood Pressure Cuff, 8); HLJ (Ophthalmoscope, Battery-Powered, 6).
Next steps
- See all 30 Rudolf Riester GmbH & Co. KG clearances with predicates and recalls
- Run predicate analysis for product code ERA, Rudolf Riester GmbH & Co. KG'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.