Cambridge Medical Instruments, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Cambridge Medical Instruments, Inc.” (first 1985, latest 1990), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 4 | 4 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| IOL | Treadmill, Powered | 1 | 1 |
Review panels
- Cardiovascular (7)
- Physical Medicine (1)
Most recent Cambridge Medical Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896772 | EKG, ECG KENZ, ECG 303 | DPS | 1990-02-26 | 87 |
| K896771 | EKG, ECG KENZ, ECG 302 | DSI | 1990-02-26 | 87 |
| K895961 | MODEL MC6500 ELECTROCARDIOGRAPH | DSH | 1990-01-04 | 86 |
| K883454 | MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH | DPS | 1989-01-25 | 163 |
| K871993 | MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPH | DPS | 1987-11-23 | 181 |
| K862748 | MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION | DPS | 1986-08-25 | 35 |
| K854282 | PREVIEW XT | DSI | 1986-01-08 | 76 |
| K854283 | CAMBRIDGE MODEL XT1000 | IOL | 1985-11-13 | 20 |
Recalls
openFDA lists no recalls under a recalling firm named Cambridge Medical Instruments, 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.
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.
- Cambridge Heart, Inc. (17 510(k)s)
- Cambridge Medical Technology (14 510(k)s)
- Cambridge Instruments, Inc. (13 510(k)s)
- Cambridge Bioscience Corp. (5 510(k)s)
- Cambridge Nuclear Corp. (5 510(k)s)
- Cambridge Chemical Products, Inc. (4 510(k)s)
- Cambridge Diagnostics Ireland, Ltd. (4 510(k)s)
- Cambridge Life Sciences Plc. (4 510(k)s)
- Cambridge Biotech Corp. (3 510(k)s)
- Cambridge Sensors Limited (3 510(k)s)
- Cambridge Scientific, Inc. (2 510(k)s)
- Cambridge Technologies, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cambridge Medical Instruments, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Cambridge Medical Instruments, Inc.” (first 1985, latest 1990), across 4 product codes in 2 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 Cambridge Medical Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cambridge Medical Instruments, Inc. is 86 days.
Which FDA product codes appear under Cambridge Medical Instruments, Inc.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 4); DSI (Detector And Alarm, Arrhythmia, 2); DSH (Recorder, Magnetic Tape, Medical, 1).
Next steps
- See all 8 Cambridge Medical Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Cambridge Medical Instruments, 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.