# K012031: Modification to Thermal Angel

- Pathway: 510(k) (Special)
- Applicant: Estill Medical Technologies, Inc.
- Decided: Jul 26, 2001 after 28 days
- Product code: BSB (Warmer, Blood, Non-Electromagnetic Radiation)
- Device class: 2
- Regulation: 21 CFR 864.9205
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K770232 (1977). 4 ancestors in all.
13 later devices descend from it; 2 cite it directly.
3 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973741: Bair Hugger Blood/Fluid Warmer, Augustine Medical, Inc. (1998) Summary page 2.
- K770232: Blood/Fluid Warmer Model DW-1000A, Gorman Rupp Industries (1977) Summary page 2.
- K911383: Hotline Fluid Warmer, Level 1 Technologies, Inc. (1991) Summary page 2.
- K984640: Thermal Angel, Estill Medical Technologies, Inc. (1999) Summary page 1.

## Most influential descendants
- K060537: Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC Power Supply, Model 120 (2006), 12 descendants of its own
- K112902: Enflow IV Fluid Warmer (2012), 10 descendants of its own
- K232107: °M Warmer System (2024), 1 descendant of its own
- K211618: Fluido Compact Blood and Fluid Warming System (2023), 1 descendant of its own
- K181775: Quantum Blood and IV Fluid Infusion Warmer (2019), 1 descendant of its own

## Recalls of this device
- Jul 25, 2014 · Class II · Z-0101-2015: Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity during a 60 minute charging period. If you have a fully discharged Ultra Battery 1 (TA-UB1), in 

## Indications for use
Thermal Angel™ model 200 Blood and Fluid Warmer is an in-line, intravenous blood and fluid warmer. Thermal Angel™ is indicated for use whenever introduction of normothermic, parenteral (intravenous or irrigation) fluids are desired or indicated, whether in field or clinical settings.

Source page: https://510kreport.com/device/K012031
Methodology: https://510kreport.com/methodology