Cleared Traditional

KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS (K011859) - FDA 510(k) Clearance

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

K011859 · Klimamed Technologie Medizingerate GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
321d
Days
Class 2
Risk

K011859 is an FDA 510(k) clearance for the KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Klimamed Technologie Medizingerate GmbH (Roseville, US). The FDA issued a Cleared decision on May 1, 2002 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Klimamed Technologie Medizingerate GmbH devices

Submission Details

510(k) Number K011859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2001
Decision Date May 01, 2002
Days to Decision 321 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 125d · This submission: 321d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K011859.
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