510(k) · Cleared
ClearedGauze Sponge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keilei Intl., Inc. · EFQ Gauze/Sponge, Internal
Cleared on Oct 23, 1989 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Oct 23, 1989
- Review
- 76 days
- Class
- Class U
- Product code
- EFQ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK895086 Gauze SpongeKeilei Intl., Inc. · 1989
- Descendant · cites it directly · 0 of its ownK961773 Protec Sterile Gauze SpongeDerivadas Degasa S.A. DE C.V. · 1996
Most influential descendants
Showing 1 of 1 · See all- K961773Protec Sterile Gauze SpongeDerivadas Degasa S.A. DE C.V. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895086 | Gauze Sponge | Keilei Intl., Inc. | 1989 | — |
| +1 | K961773 | Protec Sterile Gauze Sponge | Derivadas Degasa S.A. DE C.V. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961773 | Protec Sterile Gauze Sponge | 1996 | 0 |
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, K961773 (Derivadas Degasa S.A. DE C.V., 1996) has gone furthest, with 0 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/K895086 · printed Nov 4, 2026
Cite this page
510(k) Report. “K895086: Gauze Sponge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895086
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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