# K123308: Pulstar Logix Intermittent Pneumatic Compression System

- Pathway: 510(k) (Traditional)
- Applicant: Albahealth, LLC
- Decided: Feb 8, 2013 after 107 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 K770956 (1977). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K770956: Pas Anti-Embolism System, Hamilton Industries, Inc. (1977) Summary page 3.
- K961405: Alba Health Pas Wrap System, Alba-Waldensian, Inc. (1996) Summary page 3.

## Indications for use
Patients at risk for DVT. These include a. Major orthopedic procedures, e.g. knee surgery Major abdominal, thoracic surgery including urogemtal surgery Neurosurgery, subarachnoid hemorrhage and stroke Bedridden Medical patients b. Patients with chronic venous insufficiency Note: The indications for use of the Puistar Logix Pneumatic Compression systems are the same as predicate K770956B and K961405

Source page: https://510kreport.com/device/K123308
Methodology: https://510kreport.com/methodology