510(k) · Cleared
ClearedCollatek Sheet
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. 19 later devices descend from it.
- Decided
- Oct 25, 2001
- Review
- 49 days
- Class
- Class U
- Product code
- MGP
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 1 citing it directly.
- This deviceK012995 Collatek SheetBiocore Medical Technologies, Inc. · 2001
- Descendant · cites it directly · 18 of its ownK090160 Suprathel Wound and Burn DressingPolymedics Innovations, GmbH · 2009
- Descendant · 2 generations on · 10 of its ownK132397 Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK142879 BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015
- Descendant · 3 generations on · 4 of its ownK172140 NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing…Polynovo Biomaterials Pty, Ltd. · 2017
- Descendant · 3 generations on · 4 of its ownK170300 Restrata Wound MatrixAcera Surgical, Inc. · 2017 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH · 2009 · cites it directly18descendants
- K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014 · 2 generations on10descendants
- K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015 · 2 generations on5descendants
- K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd. · 2017 · 3 generations on4descendants
- K170300Restrata Wound MatrixAcera Surgical, Inc. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012995 | Collatek Sheet | Biocore Medical Technologies, Inc. | 2001 | — |
| +1 | K090160 | Suprathel Wound and Burn Dressing | Polymedics Innovations, GmbH | 2009 | — |
| +2 | K132397 | Gore Bio-a Wound Matrix | W. L. Gore & Associates, Inc. | 2014 | — |
| +2 | K142879 | BTM Wound Dressing | Polynovo Biomaterials Pty, Ltd. | 2015 | — |
| +3 | K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x… | Polynovo Biomaterials Pty, Ltd. | 2017 | — |
| +3 | K170300 | Restrata Wound Matrix | Acera Surgical, Inc. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | — | Cutinova® hydro Named without a submission number | |
| * | — | DuoDerm® Extra Thin Named without a submission number | |
| * | — | DuoDerm® CGF Named without a submission number | |
| * | — | hyCURE® sheet Named without a submission number |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090160 | Suprathel Wound and Burn Dressing | 2009 | 18 |
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, K090160 (Polymedics Innovations, GmbH, 2009) has gone furthest, with 18 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 Sheet may be used in the management of:
Partial and full thickness wounds
Pressure (stage 1-1V) and venous ulcers
Ulcers caused by mixed vascular etiologies
Venous stasis and diabetic ulcers
Ist and 2™ depree 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/K012995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012995: Collatek Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012995
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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