510(k) · Cleared

Cleared

Topkin Wound Dressing

K031684510(k) TraditionalCleared Oct 30, 2003153-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet Merck GmbH · QSZ Absorbable Synthetic Wound Dressing

Cleared on Oct 30, 2003 as substantially equivalent to K982939 (Bioderm, Inc., 1998) after a 153-day review. Its family tree reaches back 1 generation to 1998. 19 later devices descend from it.

Decided: Oct 30, 2003
Review: 153 days
Class: Class U
Product code: QSZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K982939 (1998). 19 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK982939 BTF Thin Film Wound DressingBioderm, Inc. · 1998
This deviceK031684 Topkin Wound DressingBiomet Merck GmbH · 2003
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

2009high 3 (2017) · low 0 (2010)2026

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
−1	K982939	BTF Thin Film Wound Dressing	Bioderm, Inc.	1998	—
0 (this device)	K031684	Topkin Wound Dressing	Biomet Merck GmbH	2003	—
+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

FIG. 1 — Lineage of K031684, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 QSZ? 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 QSZ device

#1 K254256 LUOFUCON® Wound Matrixscore 14.6 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K982939	BTF Thin Film Wound Dressing Summary page 5 …03 (2) Name of the device: TopkinB, wound dressing (3) Legally market device to which the submitter claims equivalence: BiodermB thin film wound dressing, FDA no.: IC982939 (4) Description of TopkinB: TopkinB foil is a synthetic, polymeric, transparent foil for temporary coverage of non-infected ski…	Bioderm, Inc.	1998	—

Also cleared against K982939: 1 other device →

What descends from it? (19)

See all 19

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K090160	Suprathel Wound and Burn Dressing	Polymedics Innovations, GmbH	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?

Its one ancestor has no recall.
Of its descendants, K090160 (Polymedics Innovations, GmbH, 2009) has gone furthest, with 18 descendants of its own.
1 other device also cites its predicate K982939.

How does its category compare?

All QSZ devices

QSZ Absorbable Synthetic Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · QSZ

4so far in 2026, the most since 2007

2007high 4 (2026) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QSZ

85in 2017

2007high 159 (2026) · low 85 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QSZ

No recall names QSZ since 2007.

Adverse event reports per year · QSZ

38in 2025

2007high 38 (2025) · low 0 (2007)2025

MAUDE reports naming product code QSZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	1	—	0
2015	1	—	0
2016	1	—	0
2017	3	85	0
2018	1	—	0
2019	0	—	0
2020	1	—	0
2021	0	—	0
2022	2	—	0
2023	2	—	15
2024	1	—	15
2025	2	—	38
2026	4	159	—

What is it indicated for?

For temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031684 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031684: Topkin Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031684

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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