510(k) · Cleared
Recalled · Class II · 20243M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · FRO Dressing, Wound, Drug
Cleared on Sep 4, 2020 as substantially equivalent to K123679 (3M Company, 2013) after a 157-day review. Its family tree reaches back 4 generations to 1991. It has been recalled once.
- Decided
- Sep 4, 2020
- Review
- 157 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K895920 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK895920 Vitapatch Pin Protection Device for PercutaneousVitaphore Corp. · 1991
- 3 generations backK003229 Biopatch Antimicrobial DressingIntegra Lifesciences Corp. · 2001
- 2 generations backK063458 3M Tegaderm CHG Dressing3M Company · 2007 · Recalled
- 1 generation backK123679 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Port Dressing3M Company · 2013 · Recalled
- This deviceK200835 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad3M Company · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895920 | Vitapatch Pin Protection Device for Percutaneous | Vitaphore Corp. | 1991 | — |
| −3 | K003229 | Biopatch Antimicrobial Dressing | Integra Lifesciences Corp. | 2001 | — |
| −2 | K063458 | 3M Tegaderm CHG Dressing | 3M Company | 2007 | 1 |
| −1 | K123679 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Port Dressing | 3M Company | 2013 | 1 |
| 0 (this device) | K200835 | 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad | 3M Company | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 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 |
|---|---|---|---|
| * | K123679 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Port DressingSummary page 5…Device Classification: Unclassified Product Code: FRO Predicate Device 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing, K123679 Reference Device BIOPATCH® Antimicrobial Dressing, K003229 Indications for Use The 3M™ Tegaderm™ CHG Chlorhexidine Gluconate… | 2013 |
| † | K003229 | Biopatch Antimicrobial Dressing | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2024 | Class II | Z-0038-2025 | Under Investigation by firm | Contamination with foreign substance matter |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 3M™ Tegaderm™ CHG Chlorhexidine Gluconate Gel Pad can be used to cover and protect catheter sites. Common applications include covering intravascular catheters and percutaneous devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200835: 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200835
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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