# K962288: Cover-All, Drape-IT-All, Chair Sleve, X-Ray Sleeve, Headrest Cover

- Pathway: 510(k) (Traditional)
- Applicant: Pinnacle Products, Inc.
- Decided: Jan 30, 1997 after 230 days
- Product code: MMP (Cover, Barrier, Protective)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K900093 (1990). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944198: Surgical Microscope Drape, Hydro-Med Products, Inc. (1994) Summary page 2.
- K952241: Protouch Overglove, Cottrell, Ltd. (1995) Summary page 2.
- K900093: Disposa-Shield (TM) Infection Control Barrier, Dentsply Intl. (1990) Summary page 1.

## Most influential descendants
- K014239: Medsurg Equipment Covers (2002), 1 descendant of its own
- K041501: Guangzhou Fortunique Drapes, Bags and Covers (2004), 0 descendants of its own

## Recalls of this device
- Feb 11, 2015 · Class II · Z-1291-2015: Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the 
- Jan 30, 2015 · Class II · Z-1306-2015: If the patient sits on either wing, not squarely on the center section of the Stretcher Lift, tipping and injury to the operator or patient could result. The device manual was updated with an addition
- Sep 20, 2011 · Class II · Z-0444-2013: The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light gu

## Indications for use
to act as a physical barrier, augmenting existing infection control techniques and make clean-up and disinfection easier.

Source page: https://510kreport.com/device/K962288
Methodology: https://510kreport.com/methodology