# KKX: Drape, Surgical, Antimicrobial

- Device class: 2; regulation: 21 CFR 878.4370; FDA's rule: 510(k) required
- FDA decisions: 450
- 510(k) review time 2021–2025: median 266 days (middle half 249–312)
- Recalls: 44 (7 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2010: 8
- 2011: 4
- 2012: 2
- 2013: 3
- 2014: 6
- 2015: 2
- 2017: 1
- 2020: 1
- 2021: 1
- 2023: 2

## Most-cited predicates
- K031287: Steri-Drape Surgical Drapes (2003), cited by 7
- K050322: Microtek Equipment Drapes (2005), cited by 6
- K964142: Medline Disposable Surgical Drapes and Gowns (1997), cited by 5
- K083234: Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100 Surgical Equipment Covers, Model KC 100 (2009), cited by 4
- K954824: Protector Retractor & Protector Retractor with Drape (1996), cited by 4
- K010711: Ecotract Adjustable Wound Protector/Retractor (2001), cited by 3
- K923811: Compel Surgical Drapes (1993), cited by 2
- K140250: 3M Steri-Drape CHG Antimicrobial Incise Drape (2014), cited by 2
- K052169: Imc Surgical Drapes (2005), cited by 2
- K943393: Civco Probe Boot/Cord Cover (1995), cited by 2

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