Cleared Traditional

FilteredFlo Warming Blankets (K232638) - FDA 510(k) Clearance

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

K232638 · Iob Medical, Inc. · Cardiovascular device
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Oct 2023
Decision
55d
Days
Class 2
Risk

K232638 is an FDA 510(k) clearance for the FilteredFlo Warming Blankets. 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 October 24, 2023 after a review of 55 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 K232638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2023
Decision Date October 24, 2023
Days to Decision 55 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 125d · This submission: 55d
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 Consultant

Third Party Review Group, LLC
Dave Yungvirt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K232638.
HotDog Warming Mattress + Return Electrode
K232627 · Augustine Temperature Management, LLC · Apr 2024
Cocoon Convective Warming System, Model CWS7000
K232502 · Care Essentials Pty, Ltd. · Feb 2024
Medline ComfortTemp Patient Warming System
K231211 · Medline Industries, LP · Dec 2023
The IQoolTM System
K232844 · Braincool AB · Oct 2023
Barrier EasyWarm Active Self-Warming Blanket
K232508 · Molnlycke Health Care Us, LLC · Sep 2023
IOB Temperature Management System
K231596 · Iob Medical, Inc. · Jun 2023