FDA applicant

Innercool Therapies

San Diego,, CA2 decisions2003–20040 recalls

FDA records 2 decisions for Innercool Therapies (San Diego,, CA) from 2003 to 2004: 2 510(k) clearances. All are in product code NCX (System, Hypothermia, Intravenous, Cooling). Its devices cite 9 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Innercool Therapies, Inc.”.

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 Innercool Therapies’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Innercool Therapies since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Innercool Therapies’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 “Innercool”

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

Innercool Therapies, Inc.- A Delaware Corporation 1

Innercool Therapies

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 “Innercool”