# K052055: Smisson-Cartledge Thermal Infusion System, Model Tis-1200

- Pathway: 510(k) (Traditional)
- Applicant: Smisson-Cartledge Biomedical, LLC
- Decided: Oct 26, 2006 after 454 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K852645 (1985). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032778: Large Volume Fluid Reservoir, Belmont Instrument Corp. (2003) Summary page 5.
- K032674: Belmont Fluid Management System, Model FMS2000, Belmont Instrument Corp. (2003) Summary page 5.
- K992672: Belmont Fluid Management System (FMS2000), Belmont Instrument Corp. (1999) Summary page 5.
- K983975: Belmont Fluid Management System (FMS2000), Belmont Instrument Corp. (1998) Summary page 5.
- K972284: Fluid Management System, Belmont Instrument Corp. (1997) Summary page 5.

## Cited in the summary but kept off the family tree
- K020043: 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex Bio-Tenodesis Screw, Models AR-1555B, Arthrex, Inc. (2002). The summary prints BK020043, a CBER number, which our reading took as K020043, FDA’s number for 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM… (Arthrex, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Smiths Level 1® H-1200 Fast Flow Fluid Warmer System”. Kept off the family tree. Summary page 5.

## Most influential descendants
- K202461: ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System (2022), 0 descendants of its own

## Recalls of this device
- Feb 18, 2021 · Class I · Z-1259-2021: Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
- Feb 18, 2021 · Class I · Z-1260-2021: Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
- Feb 18, 2021 · Class I · Z-1258-2021: Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.

## Indications for use
Full range from slow feed to rapid, high flow infusion of. * crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery * warmed fluid to rewarm patients after surgery or for hypothermia * warmed fluid for irrigation in urology procedures

Source page: https://510kreport.com/device/K052055
Methodology: https://510kreport.com/methodology