510(k) · Cleared
ClearedHTTP System (HTTP 2001 Controller and HTTP Warm ME Blankets)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Http Hypothermia Therapy · DWJ System, Thermal Regulating
Cleared on Apr 27, 2004 as substantially equivalent to K001546 (Mtre Advanced Technology, Ltd., 2000) and 2 other predicates after a 67-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Apr 27, 2004
- Review
- 67 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K001546 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK001546 ALLON 2001Mtre Advanced Technology, Ltd. · 2000
- This deviceK040440 HTTP System (HTTP 2001 Controller and HTTP Warm ME Blankets)Http Hypothermia Therapy · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001546 | ALLON 2001 | Mtre Advanced Technology, Ltd. | 2000 | — |
| 0 (this device) | K040440 | HTTP System (HTTP 2001 Controller and HTTP Warm ME Blankets) | Http Hypothermia Therapy | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DWJ device
- #1 K260278 ThermAffyx (TM) Patient Safety Systemscore 12.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001546 | ALLON 2001 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”. | 2000 |
| * | K003349 | Allon 2001 ModifiedSummary page 1…The HTTP System is substantially equivalent to the Allon 2001 system (MTRE Advanced Technology Ltd.) cleared under KOO0546 and K003349, and the Bair Hugger Model 750 (Augustine Medical, Inc.) Cleared under KOOl 149 in terms of… | 2000 |
| * | K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K001546.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWJ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWJ
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWJ
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWJ
2,384in 2025
MAUDE reports naming product code DWJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 106 | 0 | 52 |
| 2008 | 3 | 73 | 0 | 40 |
| 2009 | 3 | 106 | 6 | 71 |
| 2010 | 8 | 134 | 2 | 104 |
| 2011 | 4 | 180 | 7 | 136 |
| 2012 | 5 | 69 | 1 | 106 |
| 2013 | 5 | 77 | 2 | 73 |
| 2014 | 4 | 131 | 0 | 116 |
| 2015 | 0 | — | 1 | 245 |
| 2016 | 2 | — | 0 | 1,400 |
| 2017 | 5 | 153 | 3 | 1,473 |
| 2018 | 3 | 95 | 5 | 1,517 |
| 2019 | 2 | — | 3 | 2,294 |
| 2020 | 5 | 30 | 2 | 2,546 |
| 2021 | 2 | — | 1 | 2,689 |
| 2022 | 2 | — | 5 | 3,226 |
| 2023 | 6 | 42 | 0 | 3,455 |
| 2024 | 2 | — | 3 | 3,329 |
| 2025 | 3 | 131 | 0 | 2,384 |
| 2026 | 5 | 99 | 3 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040440: HTTP System (HTTP 2001 Controller and HTTP Warm ME Blankets).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040440
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026