Cleared Traditional

IOB Temperature Management System (K231596) - FDA 510(k) Clearance

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

K231596 · Iob Medical, Inc. · Cardiovascular device
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Jun 2023
Decision
29d
Days
Class 2
Risk

K231596 is an FDA 510(k) clearance for the IOB Temperature Management System. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Iob Medical, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on June 30, 2023 after a review of 29 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 Iob Medical, Inc. devices

Submission Details

510(k) Number K231596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2023
Decision Date June 30, 2023
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 31
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K231596.
FilteredFlo Warming Blankets
K232638 · Iob Medical, Inc. · Oct 2023
The IQoolTM System
K232844 · Braincool AB · Oct 2023
Barrier EasyWarm Active Self-Warming Blanket
K232508 · Molnlycke Health Care Us, LLC · Sep 2023
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