TECOTHERM NEO (T NEO)— 510(k) K140078

Name: FDA 510(k) clearance K140078
Creator: U.S. Food and Drug Administration
Published: 2014-11-14

Substantially Equivalent

Inspiration Healthcare, Ltd.

FDA 510(k) clearance K140078 for TECOTHERM NEO (T NEO), Substantially Equivalent on 2014-11-14. Applicant: Inspiration Healthcare, Ltd.. Device class: 2.

Clearance details

Applicant: Inspiration Healthcare, Ltd.
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2014-01-13
Decision date: 2014-11-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Earl Shilton, Leicester, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWJ

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K262089 — Disposable Warming Blanket2026-08-21
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K260278 — ThermAffyx(TM) Patient Safety System2026-07-08
K260903 — Hot Pink Pad Warming System2026-04-16
K252861 — Warming System2026-04-07

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K140078

K-number listed on FDA's recall record

Z-0362-2020 — TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient, depending on the therapy objective.Class II·Terminated·Tec Com Gmbh·20180814

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140078.

Data sourced from openFDA. This site is unofficial and independent of the FDA.