510(k) · Cleared
ClearedGelzone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implantech Associates, Inc. · MDA Elastomer, Silicone, For Scar Management
Cleared on Feb 7, 2002 as substantially equivalent to K964846 (Implantech Associates, Inc., 1997) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Feb 7, 2002
- Review
- 90 days
- Class
- Class I
- Product code
- MDA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K964846 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK964846 Implatech RP Medical Grade Silicone Gel SheetingImplantech Associates, Inc. · 1997
- This deviceK013732 GelzoneImplantech Associates, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964846 | Implatech RP Medical Grade Silicone Gel Sheeting | Implantech Associates, Inc. | 1997 | — |
| 0 (this device) | K013732 | Gelzone | Implantech Associates, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 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 MDA? 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? (3)
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 |
|---|---|---|---|
| * | K964846 | Implatech RP Medical Grade Silicone Gel SheetingSummary page 1…ard the formation of such scars. Substantial Equivalence Gelzone is substantially equivalent to the Implantech’s Gel Sheeting and Conform Sheeting cleared under 510(k) K964846 and K012419 respectively. Gelzone is also substantially equivalent to PMT’s Amend™ Silicone Gel Sheeting cleared under 510(k) num… | 1997 |
| * | K012419 | Conform Sheeting, Model IgelSummary page 1…ation of such scars. Substantial Equivalence Gelzone is substantially equivalent to the Implantech’s Gel Sheeting and Conform Sheeting cleared under 510(k) K964846 and K012419 respectively. Gelzone is also substantially equivalent to PMT’s Amend™ Silicone Gel Sheeting cleared under 510(k) number K972597.… | 2001 |
| * | K972597 | PMT New Beginnings Gelshapes & AmendSummary page 1…heeting cleared under 510(k) K964846 and K012419 respectively. Gelzone is also substantially equivalent to PMT’s Amend™ Silicone Gel Sheeting cleared under 510(k) number K972597. Exhibit I, Page 1 of 2 Kp1373% Page 2:.€2 Packaging and Labeling Gelzone will be provided in various lengths,… | 1997 |
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All MDA devicesMDA Elastomer, Silicone, For Scar Management: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MDA
2in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · MDA
Too few MDA 510(k)s in any year since 2007 to give a median.
Recalls per year · MDA
No recall names MDA since 2007.
Adverse event reports per year · MDA
3in 2025
MAUDE reports naming product code MDA, 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 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Gelzone is indicated for use in the management of keloid and hypertrophic scars. Gelzone may also be used prophylactically to help retard the formation of such scars.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013732 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013732: Gelzone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013732
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026