510(k) · Cleared
ClearedGelita-Spon
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 Dec 6, 2005 as substantially equivalent to K041381 (Medtronic Xomed, Inc., 2004) after a 145-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it.
- Decided
- Dec 6, 2005
- Review
- 145 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K041381 (2004). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK041381 Meropack Bioresorbable Nasal Packing and Sinus StentMedtronic Xomed, Inc. · 2004
- This deviceK051911 Gelita-SponCuramedical, BV · 2005
- Descendant · cites it directly · 1 of its ownK060878 Gelita-Spon Absorbable Gelatin Sponge, UspCuramedical, BV · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK080022 Gel-Sponge Ent, Absorbable Gelatin Sponge, UspVascular Solutions, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041381 | Meropack Bioresorbable Nasal Packing and Sinus Stent | Medtronic Xomed, Inc. | 2004 | — |
| 0 (this device) | K051911 | Gelita-Spon | Curamedical, BV | 2005 | — |
| +1 | K060878 | Gelita-Spon Absorbable Gelatin Sponge, Usp | Curamedical, BV | 2006 | 1 |
| +2 | K080022 | Gel-Sponge Ent, Absorbable Gelatin Sponge, Usp | Vascular Solutions, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041381 | Meropack Bioresorbable Nasal Packing and Sinus StentSummary page 3…g and Sinus Dressing and Sinus Stent Stent 510(k) Number K041381 K21397 Manufacturer CuraMedical, B.V. Medtronic Xomed, Inc. Medtronic Xomed, Inc. Classific… | 2004 |
| Kept off the family tree | K021397 | FDA’s K021397 is Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060878 | Gelita-Spon Absorbable Gelatin Sponge, Usp | 2006 | 1 |
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?
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 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/K051911 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051911: Gelita-Spon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051911
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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