BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850— 510(k) K060865

Clearance details

Applicant

Arizant Healthcare, Inc.

Product code

Code DWJ

Device class

Class 2

Regulation

21 CFR 870.5900

Advisory panel

Cardiovascular

Date received

2006-03-30

Decision date

2006-04-24

Decision

Substantially Equivalent

Clearance type

Special

Location

Eden Prairie, MN, US

• K262089 — Disposable Warming Blanket2026-08-21
• K261437 — Mistral-Air® Warming System2026-08-07
• K260278 — ThermAffyx(TM) Patient Safety System2026-07-08
• K260903 — Hot Pink Pad Warming System2026-04-16
• K252861 — Warming System2026-04-07

• K120412 — 3M SPOTON TEMPERATURE MONITORING SYSTEM2012-05-30
• K082217 — RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM2008-10-06
• K060939 — RANGER IRRIGATION FLUID WARMING SYSTEM2006-06-26
• K053645 — MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS2006-03-09
• K041686 — BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM2004-06-30

Death

7

Injury

679

Malfunction

17,477

Total

18,163

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0598-2018 — 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.Class II·Terminated·3M Company - Health Care Business·20180123
• Z-0599-2018 — 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.Class II·Terminated·3M Company - Health Care Business·20180123

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060865.