Cambridge Instruments, Inc.: FDA clearances and approvals
Cambridge Instruments, Inc. has 13 FDA 510(k) clearances (first 1976, latest 1981), across 8 product codes in 2 review panels. Median 510(k) review time: 25 days.
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 |
|---|---|---|---|
| DPS | Electrocardiograph | 5 | 5 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
| IOL | Treadmill, Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (10)
- Physical Medicine (1)
Most recent Cambridge Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K811121 | CENTRAL STATION MONITORING SYSTEMS | DPS | 1981-06-30 | 67 |
| K811062 | CAMPBRIDGE COMPUTRACE | DXG | 1981-05-29 | 42 |
| K803229 | 4-CHANNEL ECG TELEMETRY MON. SYST. #3045 | DRG | 1981-01-13 | 25 |
| K801224 | CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM | DXK | 1980-06-26 | 35 |
| K800566 | CAMBRIDGE VS-550 ELECTROCARDIOGRAPH | DPS | 1980-04-08 | 26 |
| K792661 | TREADMILL MODEL 3060 | IOL | 1980-02-19 | 55 |
| K791201 | SCINTISTRESS SYSTEM | DPS | 1979-09-17 | 81 |
| K790509 | CARDIOCASSETTE II, AMBULATORY ECG SYSTEM | DSH | 1979-03-23 | 8 |
| K761318 | 3038 OPTION B-COMPUT. TRANS. TERMINAL | DXH | 1977-01-06 | 10 |
| K761198 | MODEL 3044 3-CHANNEL STRESS TEST SYSTEM | DPS | 1976-12-09 | 3 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cambridge Instruments, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cambridge Instruments, Inc. have?
Cambridge Instruments, Inc. has 13 FDA 510(k) clearances (first 1976, latest 1981), across 8 product codes in 2 review panels.
How long does FDA take to clear Cambridge Instruments, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cambridge Instruments, Inc.'s cleared 510(k)s is 25 days.
What devices does Cambridge Instruments, Inc. make?
Its most frequent FDA product codes are DPS (Electrocardiograph, 5); DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 1); DSH (Recorder, Magnetic Tape, Medical, 1).
Has Cambridge Instruments, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cambridge Instruments, Inc. Related entities may recall under other names.
Next steps
- See all 13 Cambridge Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Cambridge Instruments, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.