510(k) · Cleared
ClearedHylasine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomatrix, Inc. · EMX Balloon, Epistaxis
Cleared on Mar 13, 2000 as substantially equivalent to K982731 (Xomed, Inc., 1999) and 2 other predicates after a 159-day review. Its family tree reaches back 2 generations to 1982. 35 later devices descend from it.
- Decided
- Mar 13, 2000
- Review
- 159 days
- Class
- Class I
- Product code
- EMX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K821150 (1982). 7 ancestors in all. 35 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
- 1 generation backK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
- This deviceK993362 HylasineBiomatrix, Inc. · 2000
- Descendant · cites it directly · 29 of its ownK033666 HemadermMedafor, Inc. · 2003
- Descendant · 2 generations on · 28 of its ownK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
- Descendant · 3 generations on · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007
- Descendant · 2 generations on · 11 of its ownK080818 Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008
- Descendant · cites it directly · 10 of its ownK043035 Sepragel Ent Bioresorbable Packing/StentGenzyme Corporation · 2005
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K033666HemadermMedafor, Inc. · 2003 · cites it directly29descendants
- K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007 · 2 generations on28descendants
- K072900Excelarrest FoamHemostasis, LLC · 2007 · 3 generations on19descendants
- K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008 · 2 generations on11descendants
- K043035Sepragel Ent Bioresorbable Packing/StentGenzyme Corporation · 2005 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K821150 | NU-Gauze Sponge | Johnson & Johnson Professionals, Inc. | 1982 | — |
| −1 | K984069 | Entaxis Nasal Packing | Les Laboratorires Brothier, S.A. | 1999 | — |
| 0 (this device) | K993362 | Hylasine | Biomatrix, Inc. | 2000 | — |
| +1 | K033666 | Hemaderm | Medafor, Inc. | 2003 | — |
| +2 | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and Foam | Hemostasis, LLC | 2007 | — |
| +3 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| +2 | K080818 | Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing | Hem Con Medical Technologies, Inc. | 2008 | — |
| +1 | K043035 | Sepragel Ent Bioresorbable Packing/Stent | Genzyme Corporation | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EMX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EMX device
- #1 K220326 PosiSep X BAM Hemostat Dressing/Intranasal…score 4.4 · 1 generation · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982731 | Merogel Nasal Dressing and Sinus Stent 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”. | 1999 |
| * | K984069 | Entaxis Nasal PackingSummary page 2…D DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED Xomed MeroGel™ Nasal Dressing and Sinus Stent (Xomed, K982732) ENTaxis™ Nasal Packing (Laboratoires Brothier S.A., K984069) Merocel® Nasal Dressing (Merocel Corp., K920394) 6. DESCRIPTION OF THE DEVICE Hylasine™ is a sterile, transparent, viscoelasti… | 1999 |
| * | K920394 | Merocel Epistacis KitSummary page 2…IMED Xomed MeroGel™ Nasal Dressing and Sinus Stent (Xomed, K982732) ENTaxis™ Nasal Packing (Laboratoires Brothier S.A., K984069) Merocel® Nasal Dressing (Merocel Corp., K920394) 6. DESCRIPTION OF THE DEVICE Hylasine™ is a sterile, transparent, viscoelastic gel composed of cross-linked polymers of hyalur… | 1993 |
What descends from it? (35)
See all 352 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K033666 (Medafor, Inc., 2003) has gone furthest, with 29 descendants of its own.
- 6 other devices also cite its predicate K982731.
How does its category compare?
All EMX devicesEMX Balloon, Epistaxis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMX
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · EMX
Too few EMX 510(k)s in any year since 2007 to give a median.
Recalls per year · EMX
No recall names EMX since 2007.
Adverse event reports per year · EMX
16in 2025
MAUDE reports naming product code EMX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993362 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993362: Hylasine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993362
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026