# K012276: TEMP 3

- Pathway: 510(k) (Traditional)
- Applicant: Medical Solutions, Inc.
- Decided: Aug 20, 2001 after 32 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K060851: Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the Thermal Sac Pressure Infuser (2006), 1 descendant of its own
- K120860: Infu Box Type 0412A (2012), 0 descendants of its own
- K091336: Ivnow Modular Fluid Warmer, 120V, Model Ivnow-1, Ivnow-2, Ivnow-3, Ivnow-6, Ivnow Modular Fluid Warmer 230V (2010), 0 descendants of its own

## Indications for use
THE MEDICAL SOLUTIONS, INC TEMP 3 WARMING CABINET 1S DESIGNED TO STORE, REPIDLY WARM AND MAINTAIN TEMPERATURE OF I.V. FLUID BAGS AND IRRIGATION SOLUTION BAGS PRIOR TO THEIR USE.

Source page: https://510kreport.com/device/K012276
Methodology: https://510kreport.com/methodology