FDA applicant

Cambridge Temperature Concepts, Ltd.

Cambridge, MA1 decision2011–20110 recalls

FDA records 1 decision for Cambridge Temperature Concepts, Ltd. (Cambridge, MA) in 2011: 1 510(k) clearance. All are in product code LHD (Device, Fertility Diagnostic, Proceptive). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

How often FDA has decided Cambridge Temperature Concepts, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Cambridge Temperature Concepts, Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Cambridge”

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

Cambridge Heart, Inc. 17 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 Temperature Concepts, Ltd.

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?

Other applicant names beginning “Cambridge”