# K953673: Eclipse Probe Cover

- Pathway: 510(k) (Traditional)
- Applicant: Parker Laboratories, Inc.
- Decided: Mar 14, 1996 after 220 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K974301: CLK Int'l. Sanitary Latex Probe Cover, CLK Ultrasound Probe Cover (1998), 0 descendants of its own

## Recalls of this device
- Aug 6, 2014 · Class II · Z-0145-2015: Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the Eclipse Probe Covers.

Source page: https://510kreport.com/device/K953673
Methodology: https://510kreport.com/methodology