# K060851: Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the Thermal Sac Pressure Infuser

- Pathway: 510(k) (Traditional)
- Applicant: The Smithworks Company
- Decided: Dec 22, 2006 after 269 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K770232 (1977). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has 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 10.
- K984640: Thermal Angel, Estill Medical Technologies, Inc. (1999) Summary page 10.
- K002409: Maxone, Blood, Blood Products and IV Fluid Warmer, Automatic Medical Technologies, Inc. (2001) Summary page 10.
- K921395: Hot Sack, C.F. Electronics, Inc. (1992) Summary page 10.
- K012276: TEMP 3, Medical Solutions, Inc. (2001) Summary page 10.
- K041839: 8NONE, Medical Solutions, Inc. (2005) Summary page 10.

## Most influential descendants
- K120860: Infu Box Type 0412A (2012), 0 descendants of its own

## Indications for use
The Soft Sack iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments. The FloorMount iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments. The PAK2 iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments. The Thermal Sack Pressure Infuser is a thermal maintenance device. It is intended for use as an accessory for use with iv fluid warmer devices to enhance the ability to deliver thermal normal iv fluids in the field, by insulating the bag and tubing. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in clinical and field environments. This device has not been tested for pediatric use.

Source page: https://510kreport.com/device/K060851
Methodology: https://510kreport.com/methodology