# K993362: Hylasine

- Pathway: 510(k) (Traditional)
- Applicant: Biomatrix, Inc.
- Decided: Mar 13, 2000 after 159 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: 2 generations back to K821150 (1982). 7 ancestors in all.
35 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982731: Merogel Nasal Dressing and Sinus Stent, Xomed, Inc. (1999). Our OCR of the scanned summary read K982732, FDA’s number for Synthes (Usa) Distal Radius Plate System (DRPS) (Synthes). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Xomed MeroGel™ Nasal Dressing and Sinus Stent”.
- K984069: Entaxis Nasal Packing, Les Laboratorires Brothier, S.A. (1999) Summary page 2.
- K920394: Merocel Epistacis Kit, Merocel Corp. (1993) Summary page 2.

## Most influential descendants
- K033666: Hemaderm (2003), 29 descendants of its own
- K070211: Traumarrest and Bleedarrest Hemostatic Particles and Foam (2007), 28 descendants of its own
- K072900: Excelarrest  Foam (2007), 19 descendants of its own
- K080818: Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing (2008), 11 descendants of its own
- K043035: Sepragel Ent Bioresorbable Packing/Stent (2005), 10 descendants of its own

## Indications for use
The intended use of Hylasine™ is for use in nasal/sinus cavity as space-occupying gel stent, to separate mucosal surface and to help control minimal bleeding following surgery or nasal trauma.

Source page: https://510kreport.com/device/K993362
Methodology: https://510kreport.com/methodology