510(k) Report

510(k) · Cleared

Cleared

Nasal Cease

K102742510(k) TraditionalCleared Feb 2, 2011133-day reviewClass U

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

Catalina, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

Cleared on Feb 2, 2011 as substantially equivalent to K070211 (Hemostasis, LLC, 2007) and 1 other predicate after a 133-day review. Its family tree reaches back 5 generations to 1982. 1 later device descends from it.

Decided
Feb 2, 2011
Review
133 days
Class
Class U
Product code
QSY
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K821150 (1982). 24 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2001: 3 other ancestors2003: 1 other ancestor2002: 1 other ancestor2000: 2 other ancestors1999: 2 other ancestors1998: 1 other ancestor1997: 4 other ancestors1993: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor1983: 1 other ancestor2019: 1 descendant clearedK821150 · NU-Gauze Sponge · Johnson & Johnson Professionals, Inc. · 1982K984069 · Entaxis Nasal Packing · Les Laboratorires Brothier, S.A. · 1999K993362 · Hylasine · Biomatrix, Inc. · 2000K033666 · Hemaderm · Medafor, Inc. · 2003K070211 · Traumarrest and Bleedarrest Hemostatic Particles and Foam · Hemostasis, LLC · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 13 other ancestors4 generations back: 4 other ancestors 1 generation forward: 1 descendant K070211 · Traumarrest and Bleedarrest Hemostatic Particles and Foam · Hemostasis, LLC · 2007K033666 · Hemaderm · Medafor, Inc. · 2003K993362 · Hylasine · Biomatrix, Inc. · 2000K984069 · Entaxis Nasal Packing · Les Laboratorires Brothier, S.A. · 1999K821150 · NU-Gauze Sponge · Johnson & Johnson Professionals, Inc. · 1982−50
  1. Root · 5 generations backK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
  2. 4 generations backK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
  3. 3 generations backK993362 HylasineBiomatrix, Inc. · 2000
  4. 2 generations backK033666 HemadermMedafor, Inc. · 2003
  5. 1 generation backK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
  6. This deviceK102742 Nasal CeaseCatalina, Inc. · 2011
  7. Descendant · cites it directly · 0 of its ownK183622 NasalCEASE and BleedCEASELes Laboratoires Brothier S.A. · 2019

Most influential descendants

Showing 1 of 1 · See all
  • K183622NasalCEASE and BleedCEASELes Laboratoires Brothier S.A. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K821150NU-Gauze SpongeJohnson & Johnson Professionals, Inc.1982—
−4K984069Entaxis Nasal PackingLes Laboratorires Brothier, S.A.1999—
−3K993362HylasineBiomatrix, Inc.2000—
−2K033666HemadermMedafor, Inc.2003—
−1K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC2007—
0 (this device)K102742Nasal CeaseCatalina, Inc.2011—
+1K183622NasalCEASE and BleedCEASELes Laboratoires Brothier S.A.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199110
199210
199310
199740
199810
199920
200020
200130
200210
200310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of K102742, 1982–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 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. #1 K240713 Traumagel®score 15.0 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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
*K070211Traumarrest and Bleedarrest Hemostatic Particles and Foam
Summary page 5
…d, drug Regulatory Class: Unclassified Product Code: FRO Trade Name: NasaICEASE® Substantially Equivalent to: BleedArrest® (K07021 1); NasalCEASE®(K04 1446) Description of the device: NasaICEASE® is comprised of calcium alginate and is manufactured as a sheet (…
Hemostasis, LLC2007—
*K041446Nasalcease
Summary page 5
…Regulatory Class: Unclassified Product Code: FRO Trade Name: NasaICEASE® Substantially Equivalent to: BleedArrest® (K07021 1); NasalCEASE®(K04 1446) Description of the device: NasaICEASE® is comprised of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) of interwov…
Les Laboratorires Brothier, S.A.2004—

Also cleared against K070211: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
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?

  • The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
  • None of the 24 ancestors has a recall.
  • Of its descendants, K183622 (Les Laboratoires Brothier S.A., 2019) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K070211.

How does its category compare?

All QSY devices

QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · QSY

2in 2025

2007: 132008: 72009: 92010: 72011: 82012: 72013: 32014: 62015: 62016: 52017: 12018: 52019: 42020: 12021: 12022: 22023: 72024: 42025: 22026 (partial year): 2
2007high 13 (2007) · low 1 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QSY

142in 2024

2007: 63 days median2008: 61 days median2009: 55 days median2010: 75 days median2011: 137 days median2012: 239 days median2013: 161 days median2014: 249 days median2015: 171 days median2016: 161 days median2018: 186 days median2019: 336 days median2023: 586 days median2024: 142 days median
2007high 586 (2023) · low 55 (2009)2026

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

2022: 12024: 32025: 14
2007high 14 (2025) · low 0 (2007)2025

MAUDE reports naming product code QSY, 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
2007136300
200876100
200995500
201077500
2011813700
2012723900
2013316100
2014624900
2015617100
2016516100
20171—00
2018518600
2019433600
20201—00
20211—00
20222—01
2023758600
2024414203
20252—014
20262—0—

What is it indicated for?

This device has the following intended use.

NasalCEASE is intended to be used as a topical dressing for the local management of bleeding such as minor cuts, lacerations, and abrasions. NasalCEASE is already approved for treatment of minor nosebleeds.

It is intended to be marketed and sold as an Over-The-Counter device.

The device is not intended to be used for medium or severe wounds or bleeding.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K102742: Nasal Cease.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102742

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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