Cambridge Heart, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Cambridge Heart, Inc.” (first 1996, latest 2010), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 61 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 | 8 | 8 |
| DQK | Computer, Diagnostic, Programmable | 7 | 7 |
| DRX | Electrode, Electrocardiograph | 2 | 2 |
Review panels
- Cardiovascular (17)
Most recent Cambridge Heart, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100362 | CAMBRIDGE HEART OEM | DQK | 2010-04-14 | 61 |
| K050225 | HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM | DQK | 2005-04-07 | 65 |
| K022152 | HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS | DPS | 2002-07-16 | 14 |
| K022149 | CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 | DPS | 2002-07-16 | 14 |
| K013565 | CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 | DPS | 2001-11-21 | 26 |
| K013564 | MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS | DPS | 2001-11-21 | 26 |
| K012206 | ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM | DQK | 2001-10-12 | 91 |
| K011324 | CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM | DQK | 2001-05-23 | 22 |
| K010758 | HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS | DPS | 2001-04-12 | 30 |
| K010756 | CH 2000 CARDIAC DIAGNOSTIC SYSTEM | DQK | 2001-04-12 | 30 |
7 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-04-29.
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 Medical Technology (14 510(k)s)
- Cambridge Instruments, Inc. (13 510(k)s)
- Cambridge Medical Instruments, Inc. (8 510(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 Heart, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Cambridge Heart, Inc.” (first 1996, latest 2010), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cambridge Heart, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cambridge Heart, Inc. is 61 days.
Which FDA product codes appear under Cambridge Heart, Inc.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 8); DQK (Computer, Diagnostic, Programmable, 7); DRX (Electrode, Electrocardiograph, 2).
Next steps
- See all 17 Cambridge Heart, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Cambridge Heart, 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.