Cleared Traditional

K040440 - HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)

K040440 is an FDA 510(k) clearance for HTTP SYSTEM (HTTP 2001 CONTROLLER AND H..., manufactured by Http Hypothermia Therapy. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K040440 · Http Hypothermia Therapy · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
67d
Days
Class 2
Risk

K040440 is an FDA 510(k) clearance for the HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS). Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Http Hypothermia Therapy (Jerusalem, IL). The FDA issued a Cleared decision on April 27, 2004 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K040440

510(k) Number K040440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2004
Decision Date April 27, 2004
Days to Decision 67 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 125d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWJ Device Classification - Class 2, Special Controls

Product Code DWJ System, Thermal Regulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWJ System, Thermal Regulating

All 159
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K040440.
KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET
K031728 · Klimamed Technologie Medizingerate GmbH · Oct 2004
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
K041686 · Arizant Healthcare, Inc. · Jun 2004
VITALHEAT
K040911 · Dynatherm Medical, Inc. · Jun 2004
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000
K040632 · Smiths Medical Asd, Inc. · Apr 2004
KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS
K033021 · Kimberly-Clark Corp. · Nov 2003
ALLON 2001 VERSION 5
K024128 · Mtre Advanced Technology , Ltd. · Feb 2003
K040440 · HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)
Download PDF FDA Summary Http Hypothermia Ther…