510(k) · Cleared
ClearedBenehold CHG Transparent Film Dressing (10X12CM) (8.5X12CM) (6.5X7 CM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avery Dennison Belgie Bvba · FRO Dressing, Wound, Drug
Cleared on Sep 24, 2012 as substantially equivalent to K063458 (3M Company, 2007) after a 271-day review. Its family tree reaches back 3 generations to 1991. 4 later devices descend from it.
- Decided
- Sep 24, 2012
- Review
- 271 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K895920 (1991). 4 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK895920 Vitapatch Pin Protection Device for PercutaneousVitaphore Corp. · 1991
- 2 generations backK003229 Biopatch Antimicrobial DressingIntegra Lifesciences Corp. · 2001
- 1 generation backK063458 3M Tegaderm CHG Dressing3M Company · 2007 · Recalled
- This deviceK113836 Benehold CHG Transparent Film Dressing (10X12CM) (8.5X12CM) (6.5X7 CM)Avery Dennison Belgie Bvba · 2012
- Descendant · cites it directly · 0 of its ownK170754 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm…3M Company, 3M Healthcare · 2017
- Descendant · cites it directly · 0 of its ownK170407 BD ChloraShield IV Dressing with CHG AntimicrobialAvery Dennison Belgie Bvba · 2017
- Descendant · cites it directly · 0 of its ownK152923 BD ChloraShield IV Dressing with CHG AntimicrobialAvery Dennison Belgie Bvba · 2015
- Descendant · cites it directly · 0 of its ownK133764 Chlorashield IV Dressing with CHG AntimicrobialAvery Dennison Belgie Bvba · 2014
Most influential descendants
Showing 4 of 4 · See all- K1707543M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced…3M Company, 3M Healthcare · 2017 · cites it directly0descendants
- K170407BD ChloraShield IV Dressing with CHG AntimicrobialAvery Dennison Belgie Bvba · 2017 · cites it directly0descendants
- K152923BD ChloraShield IV Dressing with CHG AntimicrobialAvery Dennison Belgie Bvba · 2015 · cites it directly0descendants
- K133764Chlorashield IV Dressing with CHG AntimicrobialAvery Dennison Belgie Bvba · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895920 | Vitapatch Pin Protection Device for Percutaneous | Vitaphore Corp. | 1991 | — |
| −2 | K003229 | Biopatch Antimicrobial Dressing | Integra Lifesciences Corp. | 2001 | — |
| −1 | K063458 | 3M Tegaderm CHG Dressing | 3M Company | 2007 | 1 |
| 0 (this device) | K113836 | Benehold CHG Transparent Film Dressing (10X12CM) (8.5X12CM) (6.5X7 CM) | Avery Dennison Belgie Bvba | 2012 | — |
| +1 | K170754 | 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V.… | 3M Company, 3M Healthcare | 2017 | — |
| +1 | K170407 | BD ChloraShield IV Dressing with CHG Antimicrobial | Avery Dennison Belgie Bvba | 2017 | — |
| +1 | K152923 | BD ChloraShield IV Dressing with CHG Antimicrobial | Avery Dennison Belgie Bvba | 2015 | — |
| +1 | K133764 | Chlorashield IV Dressing with CHG Antimicrobial | Avery Dennison Belgie Bvba | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K063458 | 3M Tegaderm CHG DressingSummary page 1…ransparent Film Dressing Common Name: Dressing, Wound, Drug Classification Name: Unclassified 3. Predicate Device(s) K063458, 3M Tegaderm CHG Dressing 4. Device Description The BeneHold GIG Transparent Film Dressing is used to cover and… | 2007 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170754 | 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced… | 2017 | 0 |
| K170407 | BD ChloraShield IV Dressing with CHG Antimicrobial | 2017 | 0 |
| K152923 | BD ChloraShield IV Dressing with CHG Antimicrobial | 2015 | 0 |
| K133764 | Chlorashield IV Dressing with CHG Antimicrobial | 2014 | 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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K170754 (3M Company, 3M Healthcare, 2017) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K063458.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The BeneHold CHG Transparent Film Dressing is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing and covering IV catheters, other intravascular catheters and percutaneous devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113836: Benehold CHG Transparent Film Dressing (10X12CM) (8.5X12CM) (6.5X7 CM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113836
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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