# K021102: DM Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Emily Iker M.D., A.P.C.
- Decided: May 8, 2002 after 34 days
- Product code: DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs))
- Device class: 2
- Regulation: 21 CFR 880.5780
- 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 K963573 (1996). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001300: D. R. Medical Controlled Pressure Garments, Confection Medicale D.R., Inc. (2000) Summary page 1.
- K963573: Elvarex, Jobst A Beiersdorf Co. (1996) Summary page 1.
- K991570: Jobst Ready-to-Wear Arm Sleeves, Beiersdorf-Jobt, Inc. (1999) Summary page 1.

## Most influential descendants
- K061411: Torbot Vascular Compression Garments (2006), 1 descendant of its own
- K111662: Venotrain Curaflow (2011), 0 descendants of its own

## Indications for use
The DM Sleeve™ is intended to be used to apply pressure to the extremities and is indicated for use in the management of: Lymphedema and other edematous conditions, phlebitis, and vascular malformations.

Source page: https://510kreport.com/device/K021102
Methodology: https://510kreport.com/methodology