# K121145: Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes, Renu Medical Reprocessed Aircast Venaflow Thigh Garme

- Pathway: 510(k) (Traditional)
- Applicant: Renu Medical, Inc.
- Decided: Jun 12, 2012 after 57 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: 2 generations back to K890938 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992454: Venaflow System, Model 30A, Aircast, Inc. (2000) Summary page 1.
- K031189: Uuhc Reprocessed Compression Sleeve Devices, University of Utah Hospitals and Clinics (2003). Our reading of the summary gave K031159, FDA’s number for Calibrating Material, Calibrating Standards (Diamond Diagnostics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ReNu Medical Reprocessed Compression Sleeves different manufactures…”.

## Indications for use
The ReNu Medical Reprocessed Aircast Venalow calf, thigh and foot DVT garments are to be used by patients in both the home and institutional settings as a nan-invasive therapeutic method to prevent deep vien thrombosis and resulting pulmonary embolism.

Source page: https://510kreport.com/device/K121145
Methodology: https://510kreport.com/methodology