# K013436: Normatec PCD

- Pathway: 510(k) (Traditional)
- Applicant: Normatec, Inc.
- Decided: Dec 21, 2001 after 66 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 K810338 (1981). 5 ancestors in all.
55 later devices descend from it; 2 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935998: Enterprise, Camp Intl., Inc. (1995) Summary page 1.
- K830577: Linear Pump #4370975, Wright Linear Pump, Inc. (1983) Summary page 1.
- K915637: Talley TM500 Sequential Multicom Compression Syst., Progressive Medical Technology, Inc. (1992) Summary page 1.
- K810338: Lympha Press, Mego Afek (1981) Summary page 1.
- K911853: Pulsatile Anti-Embolism Sys.Pump, Baxter Healthcare Corp (1991) Summary page 1.

## Most influential descendants
- K112890: Normatec MVP (2012), 52 descendants of its own
- K160608: NormaTec Pulse and NormaTec Pulse Pro (2016), 51 descendants of its own
- K182668: Rapid Reboot Compression Therapy System (2018), 38 descendants of its own
- K193354: Air Compression Therapy Device (2020), 20 descendants of its own
- K183169: Pulse 2.0, Pulse Pro 2.0 (2018), 10 descendants of its own

## Indications for use
The NormaTec PCD is 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/K013436
Methodology: https://510kreport.com/methodology