# K040440: HTTP System (HTTP 2001 Controller and HTTP Warm ME Blankets)

- Pathway: 510(k) (Traditional)
- Applicant: Http Hypothermia Therapy
- Decided: Apr 27, 2004 after 67 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001546 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001546: ALLON 2001, Mtre Advanced Technology, Ltd. (2000). Our reading of the summary gave K000546, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Allon 2001 system”.
- K003349: Allon 2001 Modified, Mtre Advanced Technology, Ltd. (2000) Summary page 1.
- K001149: Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank, Augustine Medical, Inc. (2000)

## Indications for use
The HTTP system is intended to prevent and treat Hypothermia and provide warmth to cold or shivering patients. In addition, the HTTP system should be used whenever conditions exist that could cause patients to become cold/hypothermic. The HTTP system is indicated primarily for use in hospital, intensive care units, in operating, recovery and emergency rooms, in bums units and on medical/surgical floors. This system can be used with adults patients.

Source page: https://510kreport.com/device/K040440
Methodology: https://510kreport.com/methodology