Cleared Traditional

VITALHEAT (K040911) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040911 · Dynatherm Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
75d
Days
Class 2
Risk

K040911 is an FDA 510(k) clearance for the VITALHEAT. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Dynatherm Medical, Inc. (Burlingame, US). The FDA issued a Cleared decision on June 22, 2004 after a review of 75 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.

View all Dynatherm Medical, Inc. devices

Submission Details

510(k) Number K040911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2004
Decision Date June 22, 2004
Days to Decision 75 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 125d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 30
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K040911.
Level 1 Convective Warmer
K181699 · Smiths Medical Asd, Inc. · Jul 2018
The IQoolTM Warm System
K180375 · Braincool AB · May 2018
3M Bair Hugger Model 675 Total Temperature Management System
K171373 · 3M Company · Oct 2017
BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET
K900186 · Shiley, Inc. · Apr 1990
RK2000 K-THERMIA SYSTEM
K882442 · Baxter Healthcare Corp · Sep 1988