510(k) · Cleared
ClearedCollatek Foam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocore Medical Technologies, Inc. · MGP Dressing, Wound And Burn, Occlusive
Cleared on Oct 25, 2001 after a 49-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Oct 25, 2001
- Review
- 49 days
- Class
- Class U
- Product code
- MGP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK012997 Collatek FoamBiocore Medical Technologies, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK080949 Keratec Wound DressingsKeratec Limited · 2009
- Descendant · 2 generations on · 1 of its ownK162759 KeraStat (R) GelKeranetics, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK192386 KeraStat CreamKeranetics · 2020
- Descendant · 2 generations on · 0 of its ownK182010 ProgenaMatrixCell Constructs I, LLC · 2019 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K080949Keratec Wound DressingsKeratec Limited · 2009 · cites it directly3descendants
- K162759KeraStat (R) GelKeranetics, LLC · 2017 · 2 generations on1descendant
- K192386KeraStat CreamKeranetics · 2020 · 3 generations on0descendants
- K182010ProgenaMatrixCell Constructs I, LLC · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012997 | Collatek Foam | Biocore Medical Technologies, Inc. | 2001 | — |
| +1 | K080949 | Keratec Wound Dressings | Keratec Limited | 2009 | — |
| +2 | K162759 | KeraStat (R) Gel | Keranetics, LLC | 2017 | — |
| +3 | K192386 | KeraStat Cream | Keranetics | 2020 | — |
| +2 | K182010 | ProgenaMatrix | Cell Constructs I, LLC | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 MGP? 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? (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 |
|---|---|---|---|
| * | — | VigiFOAM Named without a submission number | |
| * | — | SkinTemp Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080949 | Keratec Wound Dressings | 2009 | 3 |
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, K080949 (Keratec Limited, 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MGP devicesMGP Dressing, Wound And Burn, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGP
FDA has decided no MGP device since 2007.
Median 510(k) review, days · MGP
Too few MGP 510(k)s in any year since 2007 to give a median.
Recalls per year · MGP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGP
8in 2024
MAUDE reports naming product code MGP, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 4 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 52 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Collatek Foam may be used in the management of
Partial and full thickness wounds
Pressure (stage 1-IV) and venous ulcers
Ulcers caused by mixed vascular etiologies
Venous stasis and diabetic ulcers
1st and 2nd degree burns
Cuts, abrasions and surgical wounds
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/K012997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012997: Collatek Foam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012997
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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