# KGX: Tape And Bandage, Adhesive

- Device class: 1; regulation: 21 CFR 880.5240; FDA's rule: 510(k) exempt
- FDA decisions: 187
- Recalls: 26 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1990: 11
- 1991: 16
- 1992: 18
- 1993: 14
- 1994: 14
- 1995: 3
- 1996: 1
- 1997: 1
- 1999: 1
- 2000: 1

## Most-cited predicates
- K813265: 3M Steri-Strip Antimicrobial Skin Clos (1983), cited by 2
- K811291: Tegaderm Transparent Dressing (1981), cited by 2
- K972914: Syvek Patch (1997), cited by 2
- K910657: Qualtex Island Dressing (1991), cited by 2
- K901845: Tegaderm Brand Transparent Dressing Series 16XX (1990), cited by 1
- K895920: Vitapatch Pin Protection Device for Percutaneous (1991), cited by 1
- K943314: Adhesive Bandages with Otc Drug (1996), cited by 1
- K923235: Bioclusive MVP Transparent Dressing (1993), cited by 1
- K895353: Opsite I.V. 3000 (1989), cited by 1
- K896068: Tipstop (TM) (1990), cited by 1

Source page: https://510kreport.com/product-code/KGX
Data by year (CSV): https://510kreport.com/product-code/KGX.csv