510(k) · Cleared

Cleared

Solosite Gel Conformable Dressing

K981150510(k) TraditionalCleared Jun 22, 199883-day reviewClass U

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

Smith & Nephew, Inc. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Cleared on Jun 22, 1998 as substantially equivalent to K935096 (C.R. Bard, Inc., 1994) and 2 other predicates after an 83-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Jun 22, 1998
Review: 83 days
Class: Class U
Product code: MGQ
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K933495 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK933495 MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads)Marketing Professionals IN Medicine, Inc. · 1994
This deviceK981150 Solosite Gel Conformable DressingSmith & Nephew, Inc. · 1998
Descendant · cites it directly · 0 of its ownK122297 Enluxtra Humifiber Wound DressingBasf Venture Capital America, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all

K122297Enluxtra Humifiber Wound DressingBasf Venture Capital America, Inc. · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933495	MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads)	Marketing Professionals IN Medicine, Inc.	1994	—
0 (this device)	K981150	Solosite Gel Conformable Dressing	Smith & Nephew, Inc.	1998	—
+1	K122297	Enluxtra Humifiber Wound Dressing	Basf Venture Capital America, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K981150, 1994–2012Source: 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 MGQ? 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

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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	Applicant	Decided	Recalls
*	K935096	Biolex Impregnated Wound Dressing Summary page 2 …ication Name: Unclassified Substantially Equivalent Products: e Product Biolex™ Impregnated Wound Dressing Bard vaatlent Care Division Murray Hill, NJ (K935096) CarraGauze® Carrasyn® Hydrogel wound \| Carrington Laboratories, Inc. Dressing Saturated Pad Irving, TX (K962218) MPM GelPad™ H…	C.R. Bard, Inc.	1994	—
*	K962218	Carrasyn Hydrogel Wound Dressing,Carragauze Pads,Carragauze Strips,Carrasorb M FDG Summary page 2 …Dressing Bard vaatlent Care Division Murray Hill, NJ (K935096) CarraGauze® Carrasyn® Hydrogel wound \| Carrington Laboratories, Inc. Dressing Saturated Pad Irving, TX (K962218) MPM GelPad™ Hydrogel Saturate Dressing \| Marketing Professionals in Medicine, Inc. Arlington, TX (K933495) Restore ™ Hydrogel…	Carrington Laboratories, Inc.	1996	—
*	K933495	MPM Gelpad (Hydrogel Saturated Sterile Gauze Pads) Summary page 2 …ington Laboratories, Inc. Dressing Saturated Pad Irving, TX (K962218) MPM GelPad™ Hydrogel Saturate Dressing \| Marketing Professionals in Medicine, Inc. Arlington, TX (K933495) Restore ™ Hydrogel Impregnated Sponge By Renaissance Pharmaceutical for Hollister Inc. Libertyville IL Device Description Sol…	Marketing Professionals IN Medicine, Inc.	1994	—
*	—	Restore™ Hydrogel Impregnated Sponge Named without a submission number			—

Also cleared against K935096: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K122297	Enluxtra Humifiber Wound Dressing	Basf Venture Capital America, Inc.	2012	0

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.
Of its descendants, K122297 (Basf Venture Capital America, Inc., 2012) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K935096.

How does its category compare?

All MGQ devices

MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MGQ

1in 2017

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MGQ

Too few MGQ 510(k)s in any year since 2007 to give a median.

Recalls per year · MGQ

4in 2014

2007high 4 (2014) · low 0 (2007)2026

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

Adverse event reports per year · MGQ

5in 2025

2007high 11 (2024) · low 0 (2008)2025

MAUDE reports naming product code MGQ, 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	1	—	0	2
2010	0	—	0	3
2011	0	—	0	5
2012	0	—	0	1
2013	0	—	0	4
2014	0	—	4	10
2015	0	—	0	3
2016	0	—	0	4
2017	1	—	0	6
2018	0	—	0	2
2019	0	—	0	2
2020	0	—	0	6
2021	0	—	0	1
2022	0	—	0	0
2023	0	—	0	6
2024	0	—	0	11
2025	0	—	0	5
2026	0	—	0	—

What is it indicated for?

SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the treatment of minor conditions such as:

Minor burns

Superficial lacerations, cuts and abrasions (partial thickness wounds) and skin tears

Under the direction of a healthcare professional, SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the management of:

Venous ulcers (leg ulcers)

Surgical incisions

Diabetic foot ulcers

Pressure ulcers (including stage IV).

Additionally, SoloSite® Gel Conformable Dressing, creates a moist wound environment which assists in autolytic debridement of wounds covered with necrotic tissue.

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/K981150 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981150: Solosite Gel Conformable Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981150

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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