510(k) · Cleared
ClearedIodoflex Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oclassen Pharmaceuticals, Inc. · KMF Bandage, Liquid
Cleared on Apr 28, 1994 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Apr 28, 1994
- Review
- 90 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK940414 Iodoflex PasteOclassen Pharmaceuticals, Inc. · 1994
- Descendant · cites it directly · 6 of its ownK051542 Triosyn T40 Antimicrobial Wound DressingTriosyn Corp. · 2006
- Descendant · 2 generations on · 4 of its ownK063059 Sorbact Wound DressingAbigo Medical AB · 2007
- Descendant · 3 generations on · 1 of its ownK143151 Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive…Bsn Medical GmbH · 2015
- Descendant · cites it directly · 0 of its ownK190756 IodoflexSmith & Nephew Medical, Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK171225 Sorbact Wound Dressing-Ribbon GauzeAbigo Medical AB · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K051542Triosyn T40 Antimicrobial Wound DressingTriosyn Corp. · 2006 · cites it directly6descendants
- K063059Sorbact Wound DressingAbigo Medical AB · 2007 · 2 generations on4descendants
- K143151Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact…Bsn Medical GmbH · 2015 · 3 generations on1descendant
- K190756IodoflexSmith & Nephew Medical, Ltd. · 2019 · cites it directly0descendants
- K171225Sorbact Wound Dressing-Ribbon GauzeAbigo Medical AB · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940414 | Iodoflex Paste | Oclassen Pharmaceuticals, Inc. | 1994 | — |
| +1 | K051542 | Triosyn T40 Antimicrobial Wound Dressing | Triosyn Corp. | 2006 | — |
| +2 | K063059 | Sorbact Wound Dressing | Abigo Medical AB | 2007 | — |
| +3 | K143151 | Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact… | Bsn Medical GmbH | 2015 | — |
| +1 | K190756 | Iodoflex | Smith & Nephew Medical, Ltd. | 2019 | — |
| +3 | K171225 | Sorbact Wound Dressing-Ribbon Gauze | Abigo Medical AB | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K051542 (Triosyn Corp., 2006) has gone furthest, with 6 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 | — |
https://510kreport.com/device/K940414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940414: Iodoflex Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940414
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026