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Transwarmer

by Prism Technologies, Inc.

510(k) K934631

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK934631 Date3 Feb 1994ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2364-2019 FDA Class II initiated 8 Jul 2019

    The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequences, such as skin burns. some products do not contain the updated IFU.

    • Terminated Z-1397-2015 FDA Class II initiated 1 May 2013

    Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification

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  • Withdrawn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
IMD
Device Class
Class I
Regulation
21 CFR Part 890.5710
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Other devices from Prism Technologies, Inc.

  • Instant Warm Gel Pack

    Class I

  • Mityvac

    Class II

  • Coldgel

    Class I

  • Instant Coldgel

    Class I