510(k) · Cleared

Cleared

Gelspray Wound Dressing

K073663510(k) TraditionalCleared Jan 30, 200835-day reviewClass I21 CFR 880.5090

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

Cleared on Jan 30, 2008 as substantially equivalent to K053409 (3M Company, 2006) and 1 other predicate after a 35-day review. Its family tree reaches back 3 generations to 2001.

Decided: Jan 30, 2008
Review: 35 days
Class: Class I
Product code: KMF
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K002338 (2001). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK002338 Liquiderm Liquid Adhesive BandageClosure Medical Corp. · 2001
2 generations backK022645 CURADBeiersdorf AG · 2002
1 generation backK062602 Band-Aid (R) Brand Liquid BandageJohnson & Johnson Consumer Companies, Inc. · 2006
This deviceK073663 Gelspray Wound DressingBiocure, Inc. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K002338	Liquiderm Liquid Adhesive Bandage	Closure Medical Corp.	2001	—
−2	K022645	CURAD	Beiersdorf AG	2002	—
−1	K062602	Band-Aid (R) Brand Liquid Bandage	Johnson & Johnson Consumer Companies, Inc.	2006	—
0 (this device)	K073663	Gelspray Wound Dressing	Biocure, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K073663, 2001–2008Source: 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 KMF? 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 KMF device

#1 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall

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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	Applicant	Decided	Recalls
*	K053409	3M Liquid Bandage Summary page 1 …510(k) Numbers and Product Codes of equivalent devices. 3M company 3M Liquid Bandage; Bandage, Liquid Code: KMF (21CFR 880.5090); K053409; S.E. June 19, 2006 Johnson & Johnson Johnson & Johnson Liquid bandage; bandage, Liquid C…	3M Company	2006	—
*	K062602	Band-Aid (R) Brand Liquid Bandage Summary page 1 …090); K053409; S.E. June 19, 2006 Johnson & Johnson Johnson & Johnson Liquid bandage; bandage, Liquid Code: KMF (21 CFR880.5090); K062602; S.E. December 11,2006 Indications for Use and Intended Population GelSpray TM Liquid Bandage is indicated for use to cov…	Johnson & Johnson Consumer Companies, Inc.	2006	—

Also cleared against K053409: 1 other device →

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?

The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
None of the 4 ancestors has a recall.
1 other device also cites its predicate K053409.

How does its category compare?

All KMF devices

KMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · KMF

1in 2024

2007high 3 (2008) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KMF

213in 2009

2007high 213 (2009) · low 35 (2008)2026

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

Recalls per year · KMF

1in 2011

2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KMF

12in 2025

2007high 34 (2013) · low 2 (2008)2025

MAUDE reports naming product code KMF, 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	2	—	1	6
2008	3	35	0	2
2009	3	213	0	6
2010	1	—	0	7
2011	0	—	1	16
2012	1	—	0	3
2013	0	—	0	34
2014	2	—	0	24
2015	0	—	0	13
2016	2	—	0	18
2017	0	—	0	16
2018	1	—	0	10
2019	1	—	0	6
2020	0	—	0	8
2021	0	—	0	10
2022	0	—	0	7
2023	0	—	0	6
2024	1	—	0	6
2025	0	—	0	12
2026	0	—	0	—

What is it indicated for?

GelSpray TM Liquid Bandage is indicated for use to cover minor cuts, scrapes and minor irritations of the skin.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073663 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073663: Gelspray 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/K073663

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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