Cleared Traditional

K252861 - Warming System (FDA 510(k) Clearance)

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

K252861 · Hangzhou Tappa Medical Technology Co., Ltd. · Cardiovascular device
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Apr 2026
Decision
210d
Days
Class 2
Risk

K252861 is an FDA 510(k) clearance for the Warming System. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Hangzhou Tappa Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on April 7, 2026 after a review of 210 days - an extended review 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: 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.

View all Hangzhou Tappa Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K252861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2025
Decision Date April 07, 2026
Days to Decision 210 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
85d slower than avg
Panel avg: 125d · This submission: 210d
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 157
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K252861.
Hot Pink Pad Warming System
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Arctic Sun Temperature Management System (Model 5000)
K251974 · Medivance, Inc. · Oct 2025
Celsi Warmer
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Arctic Sun Stat Temperature Management System
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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