# K121819: Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver

- Pathway: 510(k) (Traditional)
- Applicant: Covalontechnologies, Inc.
- Decided: Aug 13, 2012 after 53 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K895920 (1991). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080620: Modification to 3M Tegaderm CHG Dressing, 3M Company-3M Health Care (2008) Summary page 1.
- K973036: 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery), 3M Tegaderm HP Transparent Dres, 3M Healthcare (1997) Summary page 1.
- K990810: Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing, Maersk Medical, Ltd. (1999) Summary page 1.
- K003229: Biopatch Antimicrobial Dressing, Integra Lifesciences Corp. (2001) Summary page 1.
- (no number) Mepitac Soft Silicone Tape: named in the summary without a submission number

## Most influential descendants
- K163529: ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) (2017), 1 descendant of its own
- K251866: Tegaderm Post-Op Transparent Antimicrobial Dressing (2025), 0 descendants of its own
- K140389: Chloraderm Antimicrobial Transparent Thin Film Dressing, 2 3/8 X 2 3/4, 4 X 4 3/4 (2014), 0 descendants of its own

## Indications for use
SurgiClear is intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures, and wires. SurgiClear may also be used to cover and secure primary dressing. SurgiClear inhibits microbial growth within the dressing and prevents external contamination.

Source page: https://510kreport.com/device/K121819
Methodology: https://510kreport.com/methodology