DWJ · System, Thermal Regulating · Chrysalis Intelligence

Device class

Class II

Regulation 870.5900

Total clearances

2020-02-28 → 2026-08-07

Last 12 months

Unique sponsors

Definition

What is System, Thermal Regulating

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).

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.5900

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Augustine Temperature Management, LLC	4	0	2024-04-18
Iob Medical, Inc.	3	0	2023-10-24
Medivance, Inc.	3	1	2025-10-24
Stihler Electronic GmbH	2	1	2026-07-08
3M Company	2	0	2021-04-29
Medline Industries, LP	1	0	2023-12-01
Molnlycke Health Care Us, LLC	1	0	2023-09-15
Encompass Group, LLC	1	0	2020-11-12
Care Essentials Pty, Ltd.	1	0	2024-02-21
Xodus Medical, Inc.	1	1	2026-04-16
The Surgical Company International B.V., doing business as TSC Life	1	1	2026-08-07
Braincool AB	1	0	2023-10-04
STERIS Corporation	1	0	2020-06-13
Hadleigh Health Technologies	1	0	2025-06-20
Hangzhou Tappa Medical Technology Co., Ltd.	1	1	2026-04-07

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
93000	CPT	—	Low	Thermal regulation systems may be used in post-operative cardiopulmonary bypass management but lack dedicated CPT code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-07	K261437	The Surgical Company International B.V., doing business as TSC Life	Mistral-Air® Warming System
2026-07-08	K260278	Stihler Electronic GmbH	ThermAffyx(TM) Patient Safety System
2026-04-16	K260903	Xodus Medical, Inc.	Hot Pink Pad Warming System
2026-04-07	K252861	Hangzhou Tappa Medical Technology Co., Ltd.	Warming System
2025-10-24	K251974	Medivance, Inc.	Arctic Sun Temperature Management System (Model 5000)
2025-06-20	K242964	Hadleigh Health Technologies	Celsi Warmer
2025-04-30	K243942	Medivance, Inc.	Arctic Sun Stat Temperature Management System
2024-04-18	K232627	Augustine Temperature Management, LLC	HotDog Warming Mattress + Return Electrode
2024-02-21	K232502	Care Essentials Pty, Ltd.	Cocoon Convective Warming System, Model CWS7000
2023-12-01	K231211	Medline Industries, LP	Medline ComfortTemp Patient Warming System
2023-10-24	K232638	Iob Medical, Inc.	FilteredFlo Warming Blankets
2023-10-04	K232844	Braincool AB	The IQoolTM System
2023-09-15	K232508	Molnlycke Health Care Us, LLC	Barrier EasyWarm Active Self-Warming Blanket
2023-06-30	K231596	Iob Medical, Inc.	IOB Temperature Management System
2023-06-29	K230866	Augustine Temperature Management, LLC	HotDog Warming Mattress + Return Electrode
2022-12-27	K221669	Iob Medical, Inc.	IOB Warming Blankets
2022-09-23	K220941	Augustine Temperature Management	HotDog Temperature Management System
2021-04-29	K210605	3M Company	3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation
2021-03-30	K210603	3M Company	3M Bair Hugger Temperature Management System (Model 675)
2020-11-12	K203085	Encompass Group, LLC	NOVA Patient Warming System
2020-09-11	K201779	Augustine Temperature Management	HotDog Temperature Management Controller
2020-09-04	K202197	Stihler Electronic GmbH	Astopad Patient Warming System
2020-06-13	K200446	STERIS Corporation	STERIS Patient Warming System
2020-02-28	K200225	Medivance, Inc.	Arctic Sun Stat Temperature Management System