510(k) Report

FDA applicant

Life Recovery Systems Hd, LLC

Durham, CT1 decision2006–20061 recall

FDA records 1 decision for Life Recovery Systems Hd, LLC (Durham, CT) in 2006: 1 510(k) clearance. All are in product code NZE (Hyperthermia Monitor). Its devices cite 1 predicate, 0 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 Life Recovery Systems Hd, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Life Recovery Systems Hd, LLC since 2007.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Life Recovery Systems Hd, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NZEHyperthermia Monitor1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K061023Thermosuit SystemLife Recovery Systems Hd, LLC · 20062cite it

What has FDA decided for it lately?

  • K061023Thermosuit SystemLife Recovery Systems Hd, LLC · 20061 recall

The one decision as Life Recovery Systems Hd, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K061023ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon…Oct 21, 2011