# K100490: Litepac, Model 682

- Pathway: 510(k) (Special)
- Applicant: ClearStream Technologies, Ltd.
- Decided: Mar 16, 2010 after 25 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K042537 (2004). 2 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072947: Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters, ClearStream Technologies, Ltd. (2008) Summary page 1.

## Most influential descendants
- K131199: Ultraverse RX Pta Balloon Dilatation Catheter (2013), 11 descendants of its own
- K150865: Metacross RX PTA Balloon Dilitation Catheter (2015), 4 descendants of its own
- K180921: Sapphire II PRO Balloon Dilatation Catheter (2018), 3 descendants of its own
- K152873: Crosstella RX Balloon Dilatation Catheter (2016), 1 descendant of its own
- K252295: Ryurei (2026), 0 descendants of its own

## Indications for use
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

Source page: https://510kreport.com/device/K100490
Methodology: https://510kreport.com/methodology