# K982818: Hospal Tipstop

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Healthcare
- Decided: Oct 21, 1998 after 71 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- 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 K896068 (1990). 1 ancestor in all.
46 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896068: Tipstop (TM), Gambro-Hospal, Inc. (1990) Summary page 1.

## Most influential descendants
- K012293: Vascular Solutions Duett Flowable Hemostat (2002), 45 descendants of its own
- K030836: D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage (2003), 44 descendants of its own
- K050511: Thrombigel Thrombin/Gelatin Foam Hemostat (2005), 25 descendants of its own
- K072900: Excelarrest  Foam (2007), 19 descendants of its own
- K050146: Vascular Solutions D-Stat Clamp Accessory (2005), 16 descendants of its own

## Indications for use
TIPSTOP is intended to be used as a sterile compression dressing for puncture of the vascular access site.

Source page: https://510kreport.com/device/K982818
Methodology: https://510kreport.com/methodology