510(k) · Cleared
ClearedSting Skin Prep Wipe (59420600)/Sting Skin Prep Swab (59420700)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KMF Bandage, Liquid
Cleared on Nov 25, 1997 as substantially equivalent to K821271 (C.R. Bard, Inc., 1982) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1982. 1 later device descends from it.
- Decided
- Nov 25, 1997
- Review
- 90 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K821271 (1982). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK821271 Bard Protective Barrier FilmC.R. Bard, Inc. · 1982
- This deviceK973228 Sting Skin Prep Wipe (59420600)/Sting Skin Prep Swab (59420700)Smith & Nephew, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK051082 Medtrade Products Skin Protective Barrier Wipe (Sterile and Preserved)Medtrade Products, Ltd. · 2005
Most influential descendants
Showing 1 of 1 · See all- K051082Medtrade Products Skin Protective Barrier Wipe (Sterile and Preserved)Medtrade Products, Ltd. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K821271 | Bard Protective Barrier Film | C.R. Bard, Inc. | 1982 | — |
| 0 (this device) | K973228 | Sting Skin Prep Wipe (59420600)/Sting Skin Prep Swab (59420700) | Smith & Nephew, Inc. | 1997 | — |
| +1 | K051082 | Medtrade Products Skin Protective Barrier Wipe (Sterile and Preserved) | Medtrade Products, Ltd. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 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
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K821271 | Bard Protective Barrier FilmSummary page 2…ng products. No-Sting Skin Prep™ is not used over open wounds, deep puncture wounds, etc. Substantiall ivalent Products: Bard Protective Barrier Film Murray Hill, NJ (K821271A) mllKare Protective Barrier Wipe Convatec, A Bristol Myers Squibb Co. Princeton, NJ 3M No Sting Barrier Film Manufactured for 3M… | 1982 |
| * | K920794 | BRND Skin Protection Prep Series 33XXSummary page 2…(K821271A) mllKare Protective Barrier Wipe Convatec, A Bristol Myers Squibb Co. Princeton, NJ 3M No Sting Barrier Film Manufactured for 3M Health Care, Minneapolis, MN (K920794) Device Description: No-Sting Skin Prep™ is a water based alcohol free liquid impregnated onto a nonwoven wipe or tufted swab a… | 1992 |
| * | — | AllKare Protective Barrier Wipe Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051082 | Medtrade Products Skin Protective Barrier Wipe (Sterile and Preserved) | 2005 | 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 2 ancestors has a recall.
- Of its descendants, K051082 (Medtrade Products, Ltd., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KMF devicesKMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KMF
213in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KMF
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMF
12in 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?
Smith & Nephew’s “No Sting Skin Prep™” is intended for use as a liquid film-forming product that when applied to intact skin, forms a film for skin attachment sites for drainage tubes, external catheters, surrounding ostomy sites and adhesive dressings. a) “No Sting Skin Prep™” applies a coating that prepares the skin for adhesives and provides a protective interface that may reduce friction during the removal of tape. “No Sting Skin Prep™” is indicated…
Read the full statement (143 words)
Smith & Nephew’s “No Sting Skin Prep™” is intended for use as a liquid film-forming product that when applied to intact skin, forms a film for skin attachment sites for drainage tubes, external catheters, surrounding ostomy sites and adhesive dressings.
a) “No Sting Skin Prep™” applies a coating that prepares the skin for adhesives and provides a protective interface that may reduce friction during the removal of tape. “No Sting Skin Prep™” is indicated for skin attachment sites for draining tubes, external catheters, surrounding ostomy sites and other adhesive dressings.
b) “No Sting Skin Prep™” can be used in sensitive stoma areas as a skin protectant and may reduce irritation from contact with body wastes and stoma fluid.
c) “No Sting Skin Prep™” forms a protective film on skin that serves as a skin protectant which may reduce exposure to urine and feces.
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/K973228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973228: Sting Skin Prep Wipe (59420600)/Sting Skin Prep Swab (59420700).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973228
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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