MODIFICATION TO THERMAL ANGEL— 510(k) K012031

Clearance details

Applicant

Estill Medical Technologies, Inc.

Product code

Code BSB

Device class

Class 2

Regulation

21 CFR 864.9205

Advisory panel

Hematology

Date received

2001-06-28

Decision date

2001-07-26

Decision

Substantially Equivalent

Clearance type

Special

Location

Dallas, TX, US

• K112639 — THE BELMONT BUDDY LITE FLUID WARMER2011-11-16
• K090508 — THE BELMONT BUDDY LITE FLUID WARMER2009-03-26
• K062774 — BELMONT BUDDY PLUS FLUID WARMER2006-10-19
• K052547 — BELMONT BUDDY FLUID WARMER2005-10-13
• K031478 — MICROHEATER2003-07-02

• K984640 — THERMAL ANGEL1999-07-01

Death

5

Malfunction

1,778

Total

1,783

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-0101-2015 — Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient.Class II·Terminated·Estill Medical Technologies, Inc·20140725

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012031.