510(k) · Cleared
ClearedIodosorb Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perstorp AB C/O Robert Joel Slomoff · KOZ Beads, Hydrophilic, For Wound Exudate Absorption
Cleared on Jan 31, 1991 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jan 31, 1991
- Review
- 83 days
- Class
- Class I
- Product code
- KOZ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK905069 Iodosorb GelPerstorp AB C/O Robert Joel Slomoff · 1991
- Descendant · cites it directly · 0 of its ownK190730 IodosorbSmith & Nephew Medical, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK122634 Iodofoam Iodophor Foam DressingProgressive Wound Care Technologies, LLC · 2013
- Descendant · cites it directly · 0 of its ownK093320 Dryodine Cadexomer-Iodine GelCollegium Pharmaceutical Incorporated · 2010
Most influential descendants
Showing 3 of 3 · See all- K190730IodosorbSmith & Nephew Medical, Ltd. · 2019 · cites it directly0descendants
- K122634Iodofoam Iodophor Foam DressingProgressive Wound Care Technologies, LLC · 2013 · cites it directly0descendants
- K093320Dryodine Cadexomer-Iodine GelCollegium Pharmaceutical Incorporated · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905069 | Iodosorb Gel | Perstorp AB C/O Robert Joel Slomoff | 1991 | — |
| +1 | K190730 | Iodosorb | Smith & Nephew Medical, Ltd. | 2019 | — |
| +1 | K122634 | Iodofoam Iodophor Foam Dressing | Progressive Wound Care Technologies, LLC | 2013 | — |
| +1 | K093320 | Dryodine Cadexomer-Iodine Gel | Collegium Pharmaceutical Incorporated | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 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 KOZ? 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
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? (3)
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, K190730 (Smith & Nephew Medical, Ltd., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KOZ devicesKOZ Beads, Hydrophilic, For Wound Exudate Absorption: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOZ
FDA has decided no KOZ device since 2007.
Median 510(k) review, days · KOZ
Too few KOZ 510(k)s in any year since 2007 to give a median.
Recalls per year · KOZ
No recall names KOZ since 2007.
Adverse event reports per year · KOZ
2in 2024
MAUDE reports naming product code KOZ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K905069 · printed Nov 4, 2026
Cite this page
510(k) Report. “K905069: Iodosorb Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K905069
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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