# K220326: PosiSep X BAM Hemostat Dressing/Intranasal Splint

- Pathway: 510(k) (Traditional)
- Applicant: Hemostasis, LLC
- Decided: Nov 14, 2022 after 283 days
- Product code: EMX (Balloon, Epistaxis)
- Device class: 1
- Regulation: 21 CFR 874.4100
- 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 K983276 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983276: Hydrofera Bacteristatic Nasal Dressing, Hydrofera, LLC (1999) Summary page 5.

## Indications for use
PosiSep® X BAM Hemostat Dressing/Intranasal Splint is indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to: » Separate tissue or structures compromised by surgical trauma; » Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; * Help control minimal bleeding following surgery or trauma; * Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and * Act as an adjunct to aid in the natural healing process PosiSep® X BAM is indicated for use as a nasal hemostat to treat epistaxis. PosiSep® X BAM is intended for use under the direction of a licensed healthcare provider.

Source page: https://510kreport.com/device/K220326
Methodology: https://510kreport.com/methodology