510(k) · Cleared
ClearedGel-Sponge Ent, Absorbable Gelatin Sponge, Usp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Cleared on Dec 9, 2008 as substantially equivalent to K060878 (Curamedical, BV, 2006) and 1 other predicate after a 341-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Dec 9, 2008
- Review
- 341 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K896068 (1990). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK896068 Tipstop (TM)Gambro-Hospal, Inc. · 1990
- 6 generations backK982818 Hospal TipstopGambro Healthcare · 1998
- 5 generations backK012293 Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002
- 4 generations backK030836 D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · Recalled
- 3 generations backK050511 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005
- 2 generations backK053644 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2006
- 1 generation backK063860 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2007
- This deviceK080022 Gel-Sponge Ent, Absorbable Gelatin Sponge, UspVascular Solutions, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896068 | Tipstop (TM) | Gambro-Hospal, Inc. | 1990 | — |
| −6 | K982818 | Hospal Tipstop | Gambro Healthcare | 1998 | — |
| −5 | K012293 | Vascular Solutions Duett Flowable Hemostat | Vascular Solutions, Inc. | 2002 | — |
| −4 | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage | Vascular Solutions, Inc. | 2003 | 3 |
| −3 | K050511 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2005 | — |
| −2 | K053644 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2006 | — |
| −1 | K063860 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2007 | — |
| 0 (this device) | K080022 | Gel-Sponge Ent, Absorbable Gelatin Sponge, Usp | Vascular Solutions, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 KHJ? 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 KHJ device
- #1 K260266 Tympendi™ (810)score 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060878 | Gelita-Spon Absorbable Gelatin Sponge, UspSummary page 1…KHJ, LYA Regulation: 21 CFR 874.3620 Predicate Device(s) The predicate device is the currently marketed Gelita-Spon Absorbable Gelatin Sponge, USP (K060878) and ThrombiGel® thrombin/gelatin foam hemostat (K063860). Device Description The Gel-Sponge ENT is a sterile, absorbable gelati… | 2006 |
| * | K063860 | Thrombigel Thrombin/Gelatin Foam HemostatSummary page 1…Predicate Device(s) The predicate device is the currently marketed Gelita-Spon Absorbable Gelatin Sponge, USP (K060878) and ThrombiGel® thrombin/gelatin foam hemostat (K063860). Device Description The Gel-Sponge ENT is a sterile, absorbable gelatin sponge, USP available in sizes ranging from a 1.5 cm2 d… | 2007 |
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 18 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 11 ancestors have a recall of any class.
How does its category compare?
All KHJ devicesKHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KHJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KHJ
46in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHJ
1in 2025
MAUDE reports naming product code KHJ, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 46 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is intended for use during and after ENT surgeries for the control of minimal bleeding by tamponade effect, blood absorption and platelet aggregation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080022 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080022: Gel-Sponge Ent, Absorbable Gelatin Sponge, Usp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080022
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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