510(k) · Cleared
Recalled · Class II · 2022Gelita-Spon Absorbable Gelatin Sponge, Usp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curamedical, BV · KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Cleared on Apr 13, 2006 as substantially equivalent to K051911 (Curamedical, BV, 2005) after a 13-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 13, 2006
- Review
- 13 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041381 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK041381 Meropack Bioresorbable Nasal Packing and Sinus StentMedtronic Xomed, Inc. · 2004
- 1 generation backK051911 Gelita-SponCuramedical, BV · 2005
- This deviceK060878 Gelita-Spon Absorbable Gelatin Sponge, UspCuramedical, BV · 2006
- Descendant · cites it directly · 0 of its ownK080022 Gel-Sponge Ent, Absorbable Gelatin Sponge, UspVascular Solutions, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080022Gel-Sponge Ent, Absorbable Gelatin Sponge, UspVascular Solutions, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041381 | Meropack Bioresorbable Nasal Packing and Sinus Stent | Medtronic Xomed, Inc. | 2004 | — |
| −1 | K051911 | Gelita-Spon | Curamedical, BV | 2005 | — |
| 0 (this device) | K060878 | Gelita-Spon Absorbable Gelatin Sponge, Usp | Curamedical, BV | 2006 | — |
| +1 | K080022 | Gel-Sponge Ent, Absorbable Gelatin Sponge, Usp | Vascular Solutions, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (1)
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 |
|---|---|---|---|
| * | K051911 | Gelita-SponSummary page 3…ble Gelatin Sponge, USP Sponge - . 510(k) Number K051911 Manufacturer CuraMedical, B.V CuraMedical, B.V. Classification # & 21 CFR 874.4780 and 21 CF… | 2005 |
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 |
|---|---|---|---|
| K080022 | Gel-Sponge Ent, Absorbable Gelatin Sponge, Usp | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2022 | Class II | Z-1768-2022 | Under Investigation by firm | In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K080022 (Vascular Solutions, Inc., 2008) has gone furthest, with 0 descendants of its own.
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.
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?
Gelita-Spon® Absorbable Gelatin Sponge, USP is indicated for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060878: Gelita-Spon Absorbable Gelatin Sponge, Usp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060878
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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