FDA applicant

Cambridge Heart, Inc.

South West Ranches, FL17 decisions1996–20101 recall

FDA records 17 decisions for Cambridge Heart, Inc. (South West Ranches, FL) from 1996 to 2010: 17 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DQK (Computer, Diagnostic, Programmable). Its devices cite 18 predicates, 12 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cambridge Heart, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cambridge Heart, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cambridge Heart, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Cambridge”

FDA records each applicant name separately; these may or may not be the same firm.

Cambridge Medical Technology 14 Cambridge Instruments, Inc. 13 Cambridge Medical Instruments, Inc. 8 Cambridge Bioscience Corp. 5 Cambridge Nuclear Corp. 5 Cambridge Chemical Products, Inc. 4 Cambridge Diagnostics Ireland, Ltd. 4 Cambridge Life Sciences Plc. 4 Cambridge Sensors Limited 3 Cambridge Biotech Corp. 3 Cambridge Scientific 2 Cambridge Technologies, Inc. 2

Cambridge Heart, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

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Other applicant names beginning “Cambridge”