510(k) · Cleared
ClearedMerocel Epistacis Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merocel Corp. · EMX Balloon, Epistaxis
Cleared on Mar 18, 1993 after a 413-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 38 later devices descend from it.
- Decided
- Mar 18, 1993
- Review
- 413 days
- Class
- Class I
- Product code
- EMX
- Recalls
- None
- Predicates
- 0
38 later devices descend from it, 2 citing it directly.
- This deviceK920394 Merocel Epistacis KitMerocel Corp. · 1993
- Descendant · cites it directly · 37 of its ownK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
- Descendant · cites it directly · 35 of its ownK993362 HylasineBiomatrix, Inc. · 2000
- Descendant · 2 generations on · 29 of its ownK033666 HemadermMedafor, Inc. · 2003
- Descendant · 3 generations on · 28 of its ownK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
- Descendant · 4 generations on · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K984069Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999 · cites it directly37descendants
- K993362HylasineBiomatrix, Inc. · 2000 · cites it directly35descendants
- K033666HemadermMedafor, Inc. · 2003 · 2 generations on29descendants
- K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007 · 3 generations on28descendants
- K072900Excelarrest FoamHemostasis, LLC · 2007 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920394 | Merocel Epistacis Kit | Merocel Corp. | 1993 | — |
| +1 | K984069 | Entaxis Nasal Packing | Les Laboratorires Brothier, S.A. | 1999 | — |
| +1 | K993362 | Hylasine | Biomatrix, Inc. | 2000 | — |
| +2 | K033666 | Hemaderm | Medafor, Inc. | 2003 | — |
| +3 | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and Foam | Hemostasis, LLC | 2007 | — |
| +4 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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), 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 4.3 · 1 generation · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (38)
See all 382 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?
- Of its descendants, K984069 (Les Laboratorires Brothier, S.A., 1999) has gone furthest, with 37 descendants of its own.
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 | — |
https://510kreport.com/device/K920394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920394: Merocel Epistacis Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920394
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026