510(k) · Cleared
ClearedNasalCEASE and BleedCEASE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Les Laboratoires Brothier S.A. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Dec 2, 2019 as substantially equivalent to K102742 (Catalina, Inc., 2011) and 2 other predicates after a 341-day review. Its family tree reaches back 6 generations to 1982.
- Decided
- Dec 2, 2019
- Review
- 341 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K821150 (1982). 25 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
- 5 generations backK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
- 4 generations backK993362 HylasineBiomatrix, Inc. · 2000
- 3 generations backK033666 HemadermMedafor, Inc. · 2003
- 2 generations backK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
- 1 generation backK102742 Nasal CeaseCatalina, Inc. · 2011
- This deviceK183622 NasalCEASE and BleedCEASELes Laboratoires Brothier S.A. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K821150 | NU-Gauze Sponge | Johnson & Johnson Professionals, Inc. | 1982 | — |
| −5 | K984069 | Entaxis Nasal Packing | Les Laboratorires Brothier, S.A. | 1999 | — |
| −4 | K993362 | Hylasine | Biomatrix, Inc. | 2000 | — |
| −3 | K033666 | Hemaderm | Medafor, Inc. | 2003 | — |
| −2 | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and Foam | Hemostasis, LLC | 2007 | — |
| −1 | K102742 | Nasal Cease | Catalina, Inc. | 2011 | — |
| 0 (this device) | K183622 | NasalCEASE and BleedCEASE | Les Laboratoires Brothier S.A. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 QSY? 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 QSY device
- #1 K240713 Traumagel®score 15.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K102742 | Nasal CeaseSummary page 5…sing, wound, drug Regulatory Class: Unclassified Product Code: FRO E. Predicate Device: For OTC use: NasalCEASE® (K102742) For prescription use: Algosteril (K922540), and ENTaxis… | 2011 |
| * | K922540 | Wound DressingSummary page 5…Code: FRO E. Predicate Device: For OTC use: NasalCEASE® (K102742) For prescription use: Algosteril (K922540), and ENTaxis (K984069) F. Device Description: BleedCEASE® and NasalCEASE® are the sa… | 1992 |
| * | K984069 | Entaxis Nasal PackingSummary page 5…For OTC use: NasalCEASE® (K102742) For prescription use: Algosteril (K922540), and ENTaxis (K984069) F. Device Description: BleedCEASE® and NasalCEASE® are the same product with the same indications for use but brand… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 7 companies; a new generation was cleared every 3.8 years on median.
- None of the 25 ancestors has a recall.
How does its category compare?
All QSY devicesQSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QSY
142in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QSY
No recall names QSY since 2007.
Adverse event reports per year · QSY
14in 2025
MAUDE reports naming product code QSY, 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 | 13 | 63 | 0 | 0 |
| 2008 | 7 | 61 | 0 | 0 |
| 2009 | 9 | 55 | 0 | 0 |
| 2010 | 7 | 75 | 0 | 0 |
| 2011 | 8 | 137 | 0 | 0 |
| 2012 | 7 | 239 | 0 | 0 |
| 2013 | 3 | 161 | 0 | 0 |
| 2014 | 6 | 249 | 0 | 0 |
| 2015 | 6 | 171 | 0 | 0 |
| 2016 | 5 | 161 | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 5 | 186 | 0 | 0 |
| 2019 | 4 | 336 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 7 | 586 | 0 | 0 |
| 2024 | 4 | 142 | 0 | 3 |
| 2025 | 2 | — | 0 | 14 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
OTC: For the local management of bleeding wounds such as minor cuts, minor lacerations, minor abrasions, and minor nosebleeds.
Prescription: For nasal epistaxis and the local management of topical wounds, including both non-infected and infected:
• Small bleeding surface wounds
• Small post-surgical incisions
• Abrasions and lacerations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183622: NasalCEASE and BleedCEASE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183622
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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