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HotDog Temperature Management Controller

by Augustine Temperature Management, LLC

510(k) K201779

HotDog Temperature Management Controller is a medical device (FDA Class II; FDA product code DWJ, System, Thermal Regulating) made by Augustine Temperature Management, LLC, cleared under FDA 510(k) K201779 on 11 Sep 2020, active as of 22 Oct 2026. 4 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK201779 Date11 Sep 2020ClearedStatusActive

Official records

Recalls

4 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-0700-2025 FDA Class II initiated 4 Dec 2024
    • Ongoing Z-0702-2025 FDA Class II initiated 4 Dec 2024
    • Ongoing Z-0701-2025 FDA Class II initiated 4 Dec 2024

    Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".

    • Completed Z-0839-2025 FDA Class II initiated 14 Mar 2022

    HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

Timeline

5 dated events

  1. Cleared FDA 510(k) K201779
  2. Recall initiated FDA recalls Z-0839-2025
  3. Recall initiated FDA recalls Z-0700-2025
  4. Recall initiated FDA recalls Z-0702-2025
  5. Recall initiated FDA recalls Z-0701-2025

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  • Withdrawn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
FDA applicant
Augustine Temperature Management
Device class
Class II
Regulation
21 CFR Part 870.5900
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

From the manufacturer

Manufacturer's product page: Learn More >

Devices cleared under K201779

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K201779
UDI-DISize and differences
Hillrom powered by Augustine Surgical HD 2083516
Augustine Temperature Management, LLC
2083516 / 208351600850011479582 —On the market
HotDog Temperature Management System WC71
Augustine Temperature Management, LLC
WC71 / WC7100850011479018 —On the market
HotDog Temperature Management System WC77
Augustine Temperature Management, LLC
WC77 / WC7700850011479025 —On the market

Similar devices

Other devices filed under FDA product code DWJ (System, Thermal Regulating).

Other devices from Augustine Temperature Management, LLC

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