CREST ELECTRONIC WARMING BLANKET— 510(k) K801253

Name: FDA 510(k) clearance K801253
Creator: U.S. Food and Drug Administration
Published: 1981-01-02

Substantially Equivalent

Penlon, Inc.

FDA 510(k) clearance K801253 for CREST ELECTRONIC WARMING BLANKET, Substantially Equivalent on 1981-01-02. Applicant: Penlon, Inc.. Device class: 2.

Clearance details

Applicant: Penlon, Inc.
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 1980-05-28
Decision date: 1981-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWJ

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K262089 — Disposable Warming Blanket2026-08-21
K261437 — Mistral-Air® Warming System2026-08-07
K260278 — ThermAffyx(TM) Patient Safety System2026-07-08
K260903 — Hot Pink Pad Warming System2026-04-16
K252861 — Warming System2026-04-07

More clearances from Penlon, Inc.

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K936046 — SIGMA ELITE1994-11-04
K902381 — PENLON BREATHING SYSTEM PRESSURE MONITOR1990-08-17
K894689 — PENLON IDP PRESSURE FAILURE ALARM1989-08-10
K844007 — PENLON PPV VAPORIZER1985-03-12
K844008 — PENLON AM1000 ANAESTHESIA MACHINE1985-03-12

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 →

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