# K961699: Equipment Covers

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Aug 23, 1996 after 113 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
Longest line of descent: 1 generation back to K931417 (1995). 1 ancestor in all.
5 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931417: Sterile Equipment Covers, Custom Medical Products, Ltd. (1995) Summary page 1.

## Most influential descendants
- K052395: Sterile Equipment Covers (2005), 1 descendant of its own
- K014239: Medsurg Equipment Covers (2002), 1 descendant of its own
- K121436: Das Medical Equipment Drapes (2013), 0 descendants of its own
- K041501: Guangzhou Fortunique Drapes, Bags and Covers (2004), 0 descendants of its own
- K023539: Steri-Spouts; Bag-Spout, Vial-Spout, Transfer Mixer; Rapidflow, Vialflow, Transflow (2002), 0 descendants of its own

## Indications for use
Both the Auto Suture* Equipment Covers** and the Sterile Equipment Covers by Custom Medical Products (K931417) are intended to cover equipment and are not intended to be as patient drapes or have patient contact.

Source page: https://510kreport.com/device/K961699
Methodology: https://510kreport.com/methodology