# K801550: 3M Germicidal Surgical Incise Drape

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Sep 17, 1981 after 441 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K140250: 3M Steri-Drape CHG Antimicrobial Incise Drape (2014), 2 descendants of its own
- K222578: 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (2023), 0 descendants of its own
- K163556: MediClear PreOp (2017), 0 descendants of its own

## Recalls of this device
- Apr 7, 2003 · Not classified · Z-0838-03: The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used.

Source page: https://510kreport.com/device/K801550
Methodology: https://510kreport.com/methodology