510(k) Report

510(k) · Cleared

Cleared

Entaxis Nasal Packing

K984069510(k) TraditionalCleared Jan 25, 199970-day reviewClass I21 CFR 874.4100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Les Laboratorires Brothier, S.A. · EMX Balloon, Epistaxis

Cleared on Jan 25, 1999 as substantially equivalent to K905314 (Les Laboratorires Brothier, S.A., 1991) and 4 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1982. 37 later devices descend from it.

Decided
Jan 25, 1999
Review
70 days
Class
Class I
Product code
EMX
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K821150 (1982). 5 ancestors in all. 37 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1993: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor2000: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared2019: 4 descendants cleared2012: 4 descendants cleared2007: 3 descendants cleared2008: 2 descendants cleared2010: 2 descendants cleared2011: 1 descendant cleared2005: 1 descendant cleared2014: 5 descendants cleared2009: 1 descendant cleared2015: 2 descendants cleared2013: 2 descendants cleared2018: 3 descendants cleared2024: 1 descendant cleared2021: 1 descendant cleared2017: 1 descendant cleared2023: 1 descendant clearedK821150 · NU-Gauze Sponge · Johnson & Johnson Professionals, Inc. · 198219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 11 descendants4 generations forward: 10 descendants5 generations forward: 5 descendants6 generations forward: 1 descendant K821150 · NU-Gauze Sponge · Johnson & Johnson Professionals, Inc. · 19820+5
  1. Root · 1 generation backK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
  2. This deviceK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
  3. Descendant · cites it directly · 35 of its ownK993362 HylasineBiomatrix, Inc. · 2000
  4. Descendant · cites it directly · 29 of its ownK033666 HemadermMedafor, Inc. · 2003
  5. Descendant · 2 generations on · 28 of its ownK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
  6. Descendant · 3 generations on · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007
  7. Descendant · 2 generations on · 11 of its ownK080818 Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2000: 12003: 12004: 12005: 12007: 32008: 22009: 12010: 22011: 12012: 42013: 22014: 52015: 22017: 12018: 32019: 42021: 12023: 12024: 1
2000high 5 (2014) · low 0 (2001)2026

Most influential descendants

Showing 5 of 37 · See all
  • K993362HylasineBiomatrix, Inc. · 2000 · cites it directly35descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K821150NU-Gauze SpongeJohnson & Johnson Professionals, Inc.1982—
0 (this device)K984069Entaxis Nasal PackingLes Laboratorires Brothier, S.A.1999—
+1K993362HylasineBiomatrix, Inc.2000—
+1K033666HemadermMedafor, Inc.2003—
+2K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC2007—
+3K072900Excelarrest FoamHemostasis, LLC2007—
+2K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199210
199310
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200310
200410
200510
200730
200820
200910
201020
201110
201240
201320
201450
201520
201710
201830
201940
202110
202310
202410
FIG. 1 — Lineage of K984069, 1982–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K220326 PosiSep X BAM Hemostat Dressing/Intranasal…score 4.3 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K905314Algoderm Alginate Wound Dressing
Summary page 2
…(nasal) (Ear, Nose & Throat 77 EMX) Common / usual name Nasal Packing Proprietary name ENTaxis™ Nasal Packing Algoderm Alginate Wound Dressing (Laboratoires Brothier, K905314) Algosteril Alginate Dressing (Laboratoires Brothier, K922540) Nu Gauze Plain Packing Strip (Johnson & Johnson, K821150) Curity…
Les Laboratorires Brothier, S.A.1991—
*K922540Wound Dressing
Summary page 2
…l Packing Proprietary name ENTaxis™ Nasal Packing Algoderm Alginate Wound Dressing (Laboratoires Brothier, K905314) Algosteril Alginate Dressing (Laboratoires Brothier, K922540) Nu Gauze Plain Packing Strip (Johnson & Johnson, K821150) Curity Petrolatum Gauze (Kendall, K973511) Merocel Nasal Packing (M…
Les Laboratorires Brothier, S.A.1992—
*K821150NU-Gauze Sponge
Summary page 2
…Alginate Wound Dressing (Laboratoires Brothier, K905314) Algosteril Alginate Dressing (Laboratoires Brothier, K922540) Nu Gauze Plain Packing Strip (Johnson & Johnson, K821150) Curity Petrolatum Gauze (Kendall, K973511) Merocel Nasal Packing (Merocel, K920394) ENTaxis™ Nasal Packings are highly confor…
Johnson & Johnson Professionals, Inc.1982—
*K973511Kendall Curity Petrolatum Gauze
Summary page 2
…ier, K905314) Algosteril Alginate Dressing (Laboratoires Brothier, K922540) Nu Gauze Plain Packing Strip (Johnson & Johnson, K821150) Curity Petrolatum Gauze (Kendall, K973511) Merocel Nasal Packing (Merocel, K920394) ENTaxis™ Nasal Packings are highly conformable, sterile, hemostatic packings designed…
Kendall Healthcare Products Co. Div.Of Tyco Health1997—
*K920394Merocel Epistacis Kit
Summary page 2
…(Laboratoires Brothier, K922540) Nu Gauze Plain Packing Strip (Johnson & Johnson, K821150) Curity Petrolatum Gauze (Kendall, K973511) Merocel Nasal Packing (Merocel, K920394) ENTaxis™ Nasal Packings are highly conformable, sterile, hemostatic packings designed for managing bleeding in the nasal cavity…
Merocel Corp.1993—

What descends from it? (37)

See all 37

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993362HylasineBiomatrix, Inc.200035
K033666HemadermMedafor, Inc.200329
K041446NasalceaseLes Laboratorires Brothier, S.A.20042
K183622NasalCEASE and BleedCEASELes Laboratoires Brothier S.A.20190

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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K993362 (Biomatrix, Inc., 2000) has gone furthest, with 35 descendants of its own.

How does its category compare?

All EMX devices

EMX Balloon, Epistaxis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EMX

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

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

2007: 32008: 32009: 32010: 32011: 102012: 12013: 32014: 12016: 12018: 32019: 122020: 52021: 22023: 32024: 122025: 16
2007high 16 (2025) · low 0 (2015)2025

MAUDE reports naming product code EMX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20080—03
20090—03
20100—03
20110—010
20120—01
20130—03
20140—01
20150—00
20160—01
20170—00
20180—03
20190—012
20200—05
20210—02
20221—00
20230—03
20240—012
20250—016
20260—0—

What is it indicated for?

ENTaxis™ Nasal Packing is intended for

Epistaxis

Post operative nasal packing

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Les Laboratorires Brothier, S.A.

5 FDA decisions under this applicant name. See the company

  • K041446NasalceaseLes Laboratorires Brothier, S.A. · 2004
  • K922540Wound DressingLes Laboratorires Brothier, S.A. · 1992
  • K905314Algoderm Alginate Wound DressingLes Laboratorires Brothier, S.A. · 1991
  • K893123Adhesive Bandages & Pads for Minor Cuts/ScrapesLes Laboratorires Brothier, S.A. · 1990

Recent decisions in EMX

The EMX category page

  • K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2022
  • K041446NasalceaseLes Laboratorires Brothier, S.A. · 2004
  • K000108Rapid Rhino-Anterior 90MM, Model RR-a 90, Rapid Rhino-Posterior 100MM, Model RR-P 100Bhk Holding · 2000
  • K993362HylasineBiomatrix, Inc. · 2000
  • K983276Hydrofera Bacteristatic Nasal DressingHydrofera, LLC · 1999

https://510kreport.com/device/K984069 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984069: Entaxis Nasal Packing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984069

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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