510(k) · Cleared
ClearedAskina Hydrocolloid/Thin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · KMF Bandage, Liquid
Cleared on Jan 28, 1999 as substantially equivalent to K881050 (Convatec, A Division of E.R. Squibb & Sons, 1988) after a 519-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jan 28, 1999
- Review
- 519 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K881050 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK881050 Duoderm (R) CGFConvatec, A Division of E.R. Squibb & Sons · 1988
- This deviceK973227 Askina Hydrocolloid/ThinB.Braun Medical, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881050 | Duoderm (R) CGF | Convatec, A Division of E.R. Squibb & Sons | 1988 | — |
| 0 (this device) | K973227 | Askina Hydrocolloid/Thin | B.Braun Medical, Inc. | 1999 | — |
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? (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 | Decided |
|---|---|---|---|
| * | K881050 | Duoderm (R) CGFSummary page 1…colloid Trade Name: Dressing Classification name: General and Plastic Surgery Class |, 80FRO 21 CFR 878.4060 SUBSTANTIAL EQUIVALENCE! TO: o Jg*'fwmm«s T | ; | | | K881050 Squibb & Sons, Inc. Device Description: In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Bra… | 1988 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K881050.
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?
Askina Hydrocolloid and Askina Hydrocolloid/Thin react with a wound exudate to form a soft gel which permits dressing removal with minimal damage to newly formed tissue. It may be used for superficial wounds e.g. minor abrasions. It may also be used for the following indications under the supervision of a healthcare professional:
Dermal Ulcers, including
Partial & Full Thickness Wounds
Pressure Ulcers, Stages I-IV
Arterial and Venous Leg Ulcers
Burns — Second Degree
Donor Sites
As an Aid in the Prevention of Skin Breakdown
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/K973227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973227: Askina Hydrocolloid/Thin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973227
Report an extraction error
Are you the manufacturer?
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