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Snuggle Warm 4000 Convective Warming System

by Sims Level 1, Inc.

510(k) K011907

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK011907 Date18 Dec 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0497-05 FDA Unclassified (pre-2012) initiated 15 Dec 2004

    Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DWJ
Device Class
Class II
Regulation
21 CFR Part 870.5900
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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