# K895353: Opsite I.V. 3000

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew United, Inc.
- Decided: Sep 28, 1989 after 27 days
- Product code: KGX (Tape And Bandage, Adhesive)
- Device class: 1
- Regulation: 21 CFR 880.5240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K080620: Modification to 3M Tegaderm CHG Dressing (2008), 7 descendants of its own
- K121819: Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver (2012), 3 descendants of its own
- K153410: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (2017), 1 descendant of its own
- 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

Source page: https://510kreport.com/device/K895353
Methodology: https://510kreport.com/methodology