# K161346: NormaTec PCD-T and PCD-B

- Pathway: 510(k) (Traditional)
- Applicant: NormaTec Industries, LP
- Decided: Jun 15, 2016 after 30 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 K810338 (1981). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013436: Normatec PCD, Normatec, Inc. (2001) Summary page 4.

## Most influential descendants
- K183328: Pulse Rx 2.0, Pulse Pro Rx 2.0 (2018), 0 descendants of its own

## Indications for use
The NormaTec PCD-T and NormaTec PCD-B are intended to apply pressure to the extremities to treat: Lymphedema and other edematous conditions, including Congenital lymphedema (Millroy's disease, lymphedema praecox, and lymphedema tarda) Post-mastectomy lymphedema Post-infection lymphedema Post-traumatic lymphedema Post-surgical lymphedema Post-radiation-treatment lymphedema Venous insufficiency Venous stasis ulceration and to prevent: Deep Vein Thrombosis

Source page: https://510kreport.com/device/K161346
Methodology: https://510kreport.com/methodology