510(k) · Cleared
ClearedSilastic Soft Sheeting
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dow Corning Wright · FRO Dressing, Wound, Drug
Cleared on Jan 3, 1990 after a 198-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jan 3, 1990
- Review
- 198 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK894226 Silastic Soft SheetingDow Corning Wright · 1990
- Descendant · cites it directly · 1 of its ownK960254 Silgel Topical Gel SheetRofil Medical USA, Inc. · 1996
- Descendant · 2 generations on · 0 of its ownK991968 Cicacare Roll-on Gel-Scar Management Liquid Gel.Smith & Nephew, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK981353 AvogelAvocet Polymer Technologies, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK974172 Silgel Topical Gel SheetNagor, Ltd. · 1998
Most influential descendants
Showing 4 of 4 · See all- K960254Silgel Topical Gel SheetRofil Medical USA, Inc. · 1996 · cites it directly1descendant
- K991968Cicacare Roll-on Gel-Scar Management Liquid Gel.Smith & Nephew, Inc. · 1999 · 2 generations on0descendants
- K981353AvogelAvocet Polymer Technologies, Inc. · 1999 · cites it directly0descendants
- K974172Silgel Topical Gel SheetNagor, Ltd. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894226 | Silastic Soft Sheeting | Dow Corning Wright | 1990 | — |
| +1 | K960254 | Silgel Topical Gel Sheet | Rofil Medical USA, Inc. | 1996 | — |
| +2 | K991968 | Cicacare Roll-on Gel-Scar Management Liquid Gel. | Smith & Nephew, Inc. | 1999 | — |
| +1 | K981353 | Avogel | Avocet Polymer Technologies, Inc. | 1999 | — |
| +1 | K974172 | Silgel Topical Gel Sheet | Nagor, Ltd. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 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 FRO? 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 FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (4)
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, K960254 (Rofil Medical USA, Inc., 1996) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
https://510kreport.com/device/K894226 · printed Nov 5, 2026
Cite this page
510(k) Report. “K894226: Silastic Soft Sheeting.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K894226
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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