Roche Medical Electronics, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Roche Medical Electronics, Inc.” (first 1976, latest 1979), across 9 product codes in 5 review panels. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | 7 | 7 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | 2 |
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 1 | 1 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 1 | 1 |
| KHP | Acid, Lactic, Enzymatic Method | 1 | 1 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 1 | 1 |
Review panels
- Obstetrics and Gynecology (8)
- Cardiovascular (3)
- Anesthesiology (2)
- Clinical Chemistry (2)
- General Hospital (1)
Most recent Roche Medical Electronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K791559 | ROCHE SENSOR ADAPTOR | KLK | 1979-11-21 | 96 |
| K791039 | FETASONDE FETAL HEART RATE VARIABILITY | HGM | 1979-09-04 | 91 |
| K791038 | FETASONDE UTERINE ACTIVITY MONITOR | HGM | 1979-09-04 | 91 |
| K791037 | FETASONDE LABOR STATUS DISPLAY | HGM | 1979-09-04 | 91 |
| K791036 | FETASONDE UTERINE WORK MONITOR | HGM | 1979-09-04 | 91 |
| K791035 | FETASONDE FETAL ACTIVITY MONITOR | HGM | 1979-09-04 | 91 |
| K790761 | FETASONDE MODEL 2108 | HGM | 1979-06-01 | 45 |
| K790421 | ROCHE LACTATE ANALYZER 640 | KHP | 1979-05-15 | 76 |
| K782089 | MONITOR, HEART RATE MODEL 103 | DRT | 1979-01-04 | 21 |
| K782088 | MONITOR, HEART RATE MODEL 105 | DRT | 1979-01-04 | 21 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Roche Medical Electronics, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Roche Medical Electronics, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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.
- Roche Diagnostics Corp. (456 510(k)s)
- Roche Diagnostic Systems, Inc. (296 510(k)s)
- Roche Molecular Systems, Inc. (52 510(k)s)
- Roche Diagnostics Operations (Rdo) (14 510(k)s)
- Roche Diabetes Care, Inc. (12 510(k)s)
- Roche Analytical Instruments, Inc. (11 510(k)s)
- Roche Diagnostics Operations (7 510(k)s)
- Roche Diagnostics/Boehringer Mannheim GmbH (3 510(k)s)
- Roche (2 510(k)s)
- Roche Professional Diagnostics (2 510(k)s)
- Roche Diabetes Care AG (1 510(k)s)
- Roche Diagnostics Hematology, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Roche Medical Electronics, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Roche Medical Electronics, Inc.” (first 1976, latest 1979), across 9 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 Roche Medical Electronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Roche Medical Electronics, Inc. is 60 days.
Which FDA product codes appear under Roche Medical Electronics, Inc.?
The most frequent FDA product codes under this applicant name are HGM (System, Monitoring, Perinatal, 7); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 2); CCE (Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling, 1).
Next steps
- See all 16 Roche Medical Electronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HGM, Roche Medical Electronics, 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.