# K061857: Model Multi-Flo IC-1545-KT/-F Intermittent Circulator

- Pathway: 510(k) (Traditional)
- Applicant: Bio Compression Systems, Inc.
- Decided: Aug 1, 2006 after 32 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K881632 (1988). 4 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932900: Aircast Venaflow System, Aircast, Inc. (1993) Summary page 2.
- K965153: Huntleigh FP5000 System Model FP5000, Huntleigh Healthcare, Inc. (1998) Summary page 2.
- K881632: Flowtron DVT System AC500 Pump, L501 Garment, Huntleigh Technology, Inc. (1988) Summary page 2.
- K043423: Model SC-3008 Sequential Circulator, Bio Compression Systems, Inc. (2005) Summary page 2.

## Most influential descendants
- K072666: Bioarterial Plus, Arterial Blood Flow Enhancement System (2007), 18 descendants of its own
- K131327: Bioarterial Plus Arterial Blood Flow Enhancement System (2013), 14 descendants of its own
- K181149: Therm-X Pro, Therm-X AT, Therm-X Pro Athlete (2018), 12 descendants of its own
- K190854: Therm-X (2019), 11 descendants of its own
- K193550: Therm-X (2020), 10 descendants of its own

## Indications for use
When used with GI-3045-T Knee/Thigh or GI-3045-K Knee garments: Intended for prophylaxis of deep vein thrombosis When used with GI-3045-F Foot garments: Intended for prophylaxis of deep vein thrombosis Enhancement of venous and arterial circulation Prevention of venous stasis ulcers Assist in healing of cutaneous ulcers Reduction of acute or chronic edema Reduction of lower limb pain due to surgery or trauma Reduction of compartmental pressures The device is intended for hospital and home use.

Source page: https://510kreport.com/device/K061857
Methodology: https://510kreport.com/methodology