NOVA Patient Warming System

FDA 510(k) K203085 · Encompass Group, LLC

Substantially Equivalent

510(k) numberK203085

Submission

Device name
NOVA Patient Warming System
Applicant
Encompass Group, LLC
Mcdonough, GA, US
Received
October 13, 2020
Decision date
November 12, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
DWJ – System, Thermal Regulating
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5900
Specialty
Cardiovascular

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).

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K260278ThermAffyx(TM) Patient Safety SystemDWJ · Traditional Stihler Electronic GmbH07/08/2026SE
K260903Hot Pink Pad Warming SystemDWJ · Traditional Xodus Medical, Inc.04/16/2026SE
K252861Warming SystemDWJ · Traditional Hangzhou Tappa Medical Technology Co., Ltd.04/07/2026SE
K251974Arctic Sun Temperature Management System (Model 5000)DWJ · Traditional Medivance, Inc.10/24/2025SE
K242964Celsi WarmerDWJ · Traditional Hadleigh Health Technologies06/20/2025SE
K243942Arctic Sun Stat Temperature Management SystemDWJ · Traditional Medivance, Inc.04/30/2025SE
K232627HotDog Warming Mattress + Return ElectrodeDWJ · Special Augustine Temperature Management, LLC04/18/2024SE
K232502Cocoon Convective Warming System, Model CWS7000DWJ · Traditional Care Essentials Pty, Ltd.02/21/2024SE

More from Care Essentials Pty, Ltd.

510(k)DeviceDecision
K982058Rotecno FR (Fluid Resistant) Surgical GownFYA · Traditional 01/14/1999SE
K982059Rotecno 2000 Surgical GownFYA · Traditional 11/30/1998SE
K760618Patient RestraintFMQ · Traditional 11/24/1976SE

Questions and answers

When was NOVA Patient Warming System cleared by the FDA?

NOVA Patient Warming System (K203085) received a 510(k) decision of Substantially Equivalent on November 12, 2020, 30 days after the submission was received.

What is the product code of K203085?

The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.