Cleared Traditional

K180834 - Altrix Precision Temperature Management...

K180834 is an FDA 510(k) clearance for Altrix Precision Temperature Management..., manufactured by Stryker Medical. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K180834 · Stryker Medical · Cardiovascular device
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Aug 2018
Decision
133d
Days
Class 2
Risk

K180834 is an FDA 510(k) clearance for the Altrix Precision Temperature Management System. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Stryker Medical (Portage, US). The FDA issued a Cleared decision on August 10, 2018 after a review of 133 days - within the typical 510(k) review window.

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

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FDA 510(k) Submission Details - K180834

510(k) Number K180834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2018
Decision Date August 10, 2018
Days to Decision 133 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
8d slower than avg
Panel avg: 125d · This submission: 133d
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 K180834.
Arctic Sun Stat Temperature Management System
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IOB Warming Blankets
K190221 · Iob Medical, Inc. · Oct 2019
Cocoon Convective Warming System
K181671 · Care Essentials Pty, Ltd. · May 2019
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