# K053398: Compass Compression Assist Handle

- Pathway: 510(k) (Traditional)
- Applicant: Semler Technologies, Inc. Dba
- Decided: Mar 10, 2006 after 94 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K973731: EZ Hold Femoral Compression Device. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K090286: Pressuremate Manual Femoral Access Compression Device (2009), 0 descendants of its own
- K072167: Comfortpress Vascular Compression Assist Device (2007), 0 descendants of its own

## Indications for use
This device is indicated for use to provide hemostasis of the femoral vascular access site following catheterization or cannulation procedures.

Source page: https://510kreport.com/device/K053398
Methodology: https://510kreport.com/methodology