# K120958: Posisep and Posisep X Hemostat Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Hemostasis, LLC
- Decided: Jul 25, 2012 after 117 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K896068 (1990). 35 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072900: Excelarrest  Foam, Hemostasis, LLC (2007) Summary page 6.
- K102459: Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge, Hemostasis, LLC (2010) Summary page 6.
- K043050: Hemcon Bandage and Hemcon Bandage Otc, Hemcon, Inc. (2005) Summary page 6.
- K072486: Modification to Hemcon Bandage and Hemcon Bandage Otc, Hem Con Medical Technologies, Inc. (2008) Summary page 6.

## Most influential descendants
- K141704: Novashield Injectable Nasal Packing and Stent (2014), 2 descendants of its own
- K122494: Posisep and Posisep X Hemostat Dressing/Intranasal Splint (2013), 2 descendants of its own
- K172179: Chitogel Endoscopic Sinus Surgery Kit (2017), 1 descendant of its own
- K230142: Epi-Stop Nasal Gel/epistaxis pack (2023), 0 descendants of its own
- K181696: ChitoZolve (2018), 0 descendants of its own

## Indications for use
PosiSep M and PosiSep X Hemostat Dressings are topical dressings for the temporary treatment of bleeding wounds such as surgical wounds (post operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. PosiSepT and PosiSep X are intended for use under the direction of a licensed healthcare provider.

Source page: https://510kreport.com/device/K120958
Methodology: https://510kreport.com/methodology