Cleared Traditional

K210605 - 3M Bair Hugger Universal Warming Gown m...

K210605 is an FDA 510(k) clearance for 3M Bair Hugger Universal Warming Gown m..., manufactured by 3M Company. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K210605 · 3M Company · Cardiovascular device
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Apr 2021
Decision
59d
Days
Class 2
Risk

K210605 is an FDA 510(k) clearance for the 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by 3M Company (Saint Paul, US). The FDA issued a Cleared decision on April 29, 2021 after a review of 59 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.

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FDA 510(k) Submission Details - K210605

510(k) Number K210605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2021
Decision Date April 29, 2021
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
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 63
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K210605.
HotDog Warming Mattress + Return Electrode
K230866 · Augustine Temperature Management, LLC · Jun 2023
IOB Warming Blankets
K221669 · Iob Medical, Inc. · Dec 2022
HotDog Temperature Management System
K220941 · Augustine Temperature Management · Sep 2022
3M Bair Hugger Temperature Management System (Model 675)
K210603 · 3M Company · Mar 2021
NOVA Patient Warming System
K203085 · Encompass Group, LLC · Nov 2020
HotDog Temperature Management Controller
K201779 · Augustine Temperature Management · Sep 2020