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TempShield DWF-1824

by Aion Biosystems, Inc.

TempShield DWF-1824 is a Class II device made by Aion Biosystems, Inc., cleared under FDA 510(k) K232010 on 4 Aug 2023 and listed in FDA GUDID since 16 Sep 2024 (UDI-DI 00197644811199), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K232010

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00197644811199 UDI-DI Date16 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK232010 Date4 Aug 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232010 decided 4 Aug 2023 Active
  • FDA GUDID UDI-DI 00197644811199 listed 16 Sep 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232010
  2. Listed FDA GUDID 00197644811199

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TempShield
Generic name
Wireless patient thermometer, single-use
Model / reference
DWF-1824
Primary DI / UDI-DI
00197644811199
510(k) Number
FDA product code
FLL
GMDN term
Wireless patient thermometer, single-use
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Wireless patient thermometer, single-use

Other devices from Aion Biosystems, Inc.

  • iTEMPSHIELD

    Class II

  • AION TempShield

    Class II

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)