510(k) · Cleared
ClearedNU-Gauze Sponge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · EFQ Gauze/Sponge, Internal
Cleared on Aug 27, 1982 after a 126-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 68 later devices descend from it.
- Decided
- Aug 27, 1982
- Review
- 126 days
- Class
- Class U
- Product code
- EFQ
- Recalls
- None
- Predicates
- 0
68 later devices descend from it, 2 citing it directly.
- This deviceK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
- Descendant · cites it directly · 37 of its ownK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
- Descendant · cites it directly · 36 of its ownK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- Descendant · 2 generations on · 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
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K984069Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999 · cites it directly37descendants
- K072474Quikclot EXZ-Medica Corporation · 2007 · cites it directly36descendants
- K993362HylasineBiomatrix, Inc. · 2000 · 2 generations on35descendants
- K033666HemadermMedafor, Inc. · 2003 · 2 generations on29descendants
- K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K821150 | NU-Gauze Sponge | Johnson & Johnson Professionals, Inc. | 1982 | — |
| +1 | K984069 | Entaxis Nasal Packing | Les Laboratorires Brothier, S.A. | 1999 | — |
| +1 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| +2 | K993362 | Hylasine | Biomatrix, Inc. | 2000 | — |
| +2 | K033666 | Hemaderm | Medafor, Inc. | 2003 | — |
| +3 | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and 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 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2026 | 2 | 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 EFQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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? (68)
See all 682 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 EFQ devicesEFQ Gauze/Sponge, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EFQ
FDA has decided no EFQ device since 2007.
Median 510(k) review, days · EFQ
Too few EFQ 510(k)s in any year since 2007 to give a median.
Recalls per year · EFQ
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EFQ
51in 2025
MAUDE reports naming product code EFQ, 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 | 4 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 0 | — | 0 | 53 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 1 | 8 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 6 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 3 | — |
https://510kreport.com/device/K821150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K821150: NU-Gauze Sponge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K821150
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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