# K961405: Alba Health Pas Wrap System

- Pathway: 510(k) (Traditional)
- Applicant: Alba-Waldensian, Inc.
- Decided: Dec 26, 1996 after 259 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Jobst Athrombic Pump System 2000: named in the summary without a submission number
- (no number) PAS-Pulsatile Anti-Embolism System: named in the summary without a submission number

## Most influential descendants
- K024074: Reprocessed Compression Sleeves (2003), 1 descendant of its own
- K123308: Pulstar Logix Intermittent Pneumatic Compression System (2013), 0 descendants of its own
- K100909: Reprocessed Compression Sleeves (2010), 0 descendants of its own
- K052691: Suretek Medical Reprocessed Compression Sleeves (2006), 0 descendants of its own

## Recalls of this device
- Oct 12, 2011 · Not classified · Z-0183-2012: The wrap portion of the device was tearing at the seam.

Source page: https://510kreport.com/device/K961405
Methodology: https://510kreport.com/methodology