Robert Bosch Corp.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Robert Bosch Corp.” (first 1979, latest 1986), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 5 | 5 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 4 | 4 |
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| ISA | Massager, Therapeutic, Electric | 1 | 1 |
| ISB | Stimulator, Muscle, Diagnostic | 1 | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Robert Bosch Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K854493 | ERG 555 COUCH ERGOMETER | DRT | 1986-06-16 | 216 |
| K854492 | ERG 551 ERGOMETER, BICYCLE | DRT | 1986-06-16 | 216 |
| K854491 | ERG 550 ERGOMETER BICYCLE | DRT | 1986-06-16 | 216 |
| K853541 | SP 4 | — | 1986-03-28 | 214 |
| K853154 | HV-4 | IPF | 1986-03-28 | 242 |
| K853271 | HEARING AID ANALYSIS SYSTEM | ETW | 1986-01-16 | 164 |
| K851485 | DEFI 502 | LDD | 1985-08-29 | 136 |
| K840717 | ECS 502 | DRT | 1985-08-19 | 549 |
| K851937 | SONOMED 4 | IMI | 1985-07-17 | 93 |
| K850188 | BOSCH IN THE EAR HEARING AID SUPERSTAR | ESD | 1985-04-09 | 81 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Robert Bosch Corp..
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.
Device clinical trials
An industry sponsor named Robert Bosch Corp. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07466264: Contactless Human-Machine-Interface Based on Magnetometers for Consumer Applications (Recruiting, started 2024-06-21)
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.
- Robert I. Chien & Assoc., Inc. (6 510(k)s)
- Robert R. Moore (5 510(k)s)
- Robert W. Bauer & Assoc., Inc. (3 510(k)s)
- Robert A James (2 510(k)s)
- Robert B. Scott Ocularists of Florida, Inc. (2 510(k)s)
- Robert R. Stevens (2 510(k)s)
- Robert Reid, Inc. (2 510(k)s)
- Robert Bosch Healthcare Systems, Inc. (1 510(k)s)
- Robert Busse & Co., Inc. (1 510(k)s)
- Robert C. Cameron (1 510(k)s)
- Robert C. Leif, Ph.D. (1 510(k)s)
- Robert E. Fenzl, M.D. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Robert Bosch Corp.?
FDA lists 21 510(k) clearances under the applicant name “Robert Bosch Corp.” (first 1979, latest 1986), across 10 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 Robert Bosch Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Robert Bosch Corp. is 68 days.
Which FDA product codes appear under Robert Bosch Corp.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 5); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 4); IPF (Stimulator, Muscle, Powered, 3).
Next steps
- See all 21 Robert Bosch Corp. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Robert Bosch Corp.'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.