510(k) · Cleared
ClearedBiopatch Antimicrobial Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · SEL Securement Wound Dressing For Reduction Of Infection
Cleared on Oct 26, 2001 as substantially equivalent to K895920 (Vitaphore Corp., 1991) after a 381-day review. Its family tree reaches back 1 generation to 1991. 31 later devices descend from it.
- Decided
- Oct 26, 2001
- Review
- 381 days
- Class
- Class U
- Product code
- SEL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895920 (1991). 31 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK895920 Vitapatch Pin Protection Device for PercutaneousVitaphore Corp. · 1991
- This deviceK003229 Biopatch Antimicrobial DressingIntegra Lifesciences Corp. · 2001
- Descendant · cites it directly · 16 of its ownK063458 3M Tegaderm CHG Dressing3M Company · 2007 · Recalled
- Descendant · cites it directly · 9 of its ownK080779 Irrisept Wound Cleansing SystemIrrimax Corporation · 2009 · Recalled
- Descendant · 2 generations on · 7 of its ownK202222 Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation · 2020
- Descendant · 2 generations on · 7 of its ownK080620 Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 2008 · Recalled
- Descendant · 3 generations on · 6 of its ownK210536 Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2021
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K0634583M Tegaderm CHG Dressing3M Company · 2007 · cites it directly16descendants
- K080779Irrisept Wound Cleansing SystemIrrimax Corporation · 2009 · cites it directly9descendants
- K202222Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation · 2020 · 2 generations on7descendants
- K080620Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 2008 · 2 generations on7descendants
- K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2021 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895920 | Vitapatch Pin Protection Device for Percutaneous | Vitaphore Corp. | 1991 | — |
| 0 (this device) | K003229 | Biopatch Antimicrobial Dressing | Integra Lifesciences Corp. | 2001 | — |
| +1 | K063458 | 3M Tegaderm CHG Dressing | 3M Company | 2007 | 1 |
| +1 | K080779 | Irrisept Wound Cleansing System | Irrimax Corporation | 2009 | 2 |
| +2 | K202222 | Irrisept Wound Debridement and Cleansing System | Irrimax Corporation | 2020 | — |
| +2 | K080620 | Modification to 3M Tegaderm CHG Dressing | 3M Company-3M Health Care | 2008 | 1 |
| +3 | K210536 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 SEL? 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? (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 |
|---|---|---|---|
| * | K895920 | Vitapatch Pin Protection Device for PercutaneousSummary page 5…d The proposed BIOPATCH* Antimicrobial Dressing is the same (material type, manufacturing methods, sterilization type) as the existing BIOPATCH* Antimicrobial Dressing (K895920). BIOPATCH* Antimicrobial Dressing is an absorptive foam with chlorhexidine gluconate, a well-known antiseptic agent with broad… | 1991 |
What descends from it? (31)
See all 318 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063458 | 3M Tegaderm CHG Dressing | 2007 | 16 |
| K080779 | Irrisept Wound Cleansing System | 2009 | 9 |
| K121819 | Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver | 2012 | 3 |
| K153410 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 2017 | 1 |
| K093729 | Guardiva Antimicrobial Haemostatic IV Dressing, 1 in/ 4MM, Sterile, Guard Iva… | 2010 | 1 |
| K200641 | HaloGUARD Protective Disc with CHG | 2020 | 0 |
| K120930 | CHG Antibacterial Foam Dressing, CHG Antibacterial Patch, CHG Antibacterial Foam Patch… | 2012 | 0 |
| K103106 | Chlorashield TM Antimicrobial Dressing | 2011 | 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?
- Its one ancestor has no recall.
- Of its descendants, K063458 (3M Company, 2007) has gone furthest, with 16 descendants of its own.
How does its category compare?
All SEL devicesSEL Securement Wound Dressing For Reduction Of Infection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · SEL
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · SEL
Too few SEL 510(k)s in any year since 2007 to give a median.
Recalls per year · SEL
No recall names SEL since 2007.
Adverse event reports per year · SEL
No MAUDE report names SEL since 2007.
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 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
BIOPATCH* Antimicrobial Dressing containing Chlorhexidine gluconate is intended for use as a hydrophilic wound dressing that is used to absorb exudate and to cover a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, peripherally inserted coronary catheters, mid-line catheter, drains, chest tubes, externally placed orthopedic pins, and epidural catheters. It is also intended to reduce local infections, catheter related blood stream infections (CRBSI), and skin colonization of microorganisms commonly related to CRBSI, in patients with central venous or arterial catheters.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K003229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003229: Biopatch Antimicrobial Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003229
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026