# K965153: Huntleigh FP5000 System Model FP5000

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Inc.
- Decided: Jan 26, 1998 after 399 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
No predicates in its family tree.
24 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) PlexiPulse system: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- Kendall: AV5000 System. Number could not be read Summary page 1.

## Most influential descendants
- K061857: Model Multi-Flo IC-1545-KT/-F Intermittent Circulator (2006), 22 descendants of its own
- 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

## Indications for use
Prevention of deep vein thrombosis Enhancement of venous & arterial circulation Prevention of venous stasis Assist healing of cutaneous ulcers Reduction of acute or chronic edema Reduction of lower limb pain due to surgery or trauma Reduction of compartmental pressures

Source page: https://510kreport.com/device/K965153
Methodology: https://510kreport.com/methodology