# K961029: Kiltex Probe Cover

- Pathway: 510(k) (Traditional)
- Applicant: Kiltex Corp.
- Decided: Jul 25, 1996 after 133 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895614 (1989). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895614: Civco Latex Ultrasound Sheaths, CIVCO Medical Instruments Co., Inc. (1989) Summary page 1.

## Most influential descendants
- K974301: CLK Int'l. Sanitary Latex Probe Cover, CLK Ultrasound Probe Cover (1998), 0 descendants of its own

## Recalls of this device
- Nov 22, 2017 · Class III · Z-2332-2018: The incorrect IFU was shipped with the product.
- Nov 22, 2017 · Class III · Z-2333-2018: The incorrect IFU was shipped with the product.

Source page: https://510kreport.com/device/K961029
Methodology: https://510kreport.com/methodology