# K931417: Sterile Equipment Covers

- Pathway: 510(k) (Traditional)
- Applicant: Custom Medical Products, Ltd.
- Decided: Jul 6, 1995 after 836 days
- Product code: MMP (Cover, Barrier, Protective)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K050322: Microtek Equipment Drapes (2005), 9 descendants of its own
- K961699: Equipment Covers (1996), 5 descendants of its own
- K112782: Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories (2011), 2 descendants of its own
- K081476: Surgical Concept Designs Positionor Surgical Drape (2008), 1 descendant of its own
- K052395: Sterile Equipment Covers (2005), 1 descendant of its own

Source page: https://510kreport.com/device/K931417
Methodology: https://510kreport.com/methodology