510(k) · Cleared
ClearedNasalcease
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Les Laboratorires Brothier, S.A. · EMX Balloon, Epistaxis
Cleared on Jul 1, 2004 as substantially equivalent to K984069 (Les Laboratorires Brothier, S.A., 1999) after a 30-day review. Its family tree reaches back 2 generations to 1982. 2 later devices descend from it.
- Decided
- Jul 1, 2004
- Review
- 30 days
- Class
- Class I
- Product code
- EMX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K821150 (1982). 6 ancestors in all. 2 later devices descend from it, 1 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 deviceK041446 NasalceaseLes Laboratorires Brothier, S.A. · 2004
- Descendant · cites it directly · 1 of its ownK102742 Nasal CeaseCatalina, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK183622 NasalCEASE and BleedCEASELes Laboratoires Brothier S.A. · 2019
Most influential descendants
Showing 2 of 2 · See allView 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) | K041446 | Nasalcease | Les Laboratorires Brothier, S.A. | 2004 | — |
| +1 | K102742 | Nasal Cease | Catalina, Inc. | 2011 | — |
| +2 | K183622 | NasalCEASE and BleedCEASE | Les Laboratoires Brothier S.A. | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2019 | 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 4.3 · 1 generation · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K984069 | Entaxis Nasal Packing Our reading of the summary gave K985069, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ENTaxis”. | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102742 | Nasal Cease | 2011 | 1 |
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 22 years and passes through 2 companies; a new generation was cleared every 16.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K102742 (Catalina, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K984069.
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?
This device has the following intended use.
1. NasaICEASETM is intended to be inserted into the anterior nasal cavity to stop minor nosebleeds. It is intended to be marketed and sold as an Over-The-Counter device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041446: Nasalcease.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041446
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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