# K974301: CLK Int'l. Sanitary Latex Probe Cover, CLK Ultrasound Probe Cover

- Pathway: 510(k) (Traditional)
- Applicant: Clk Intl., Inc.
- Decided: Feb 6, 1998 after 81 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K895614 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K943393: Civco Probe Boot/Cord Cover, CIVCO Medical Instruments Co., Inc. (1995) Summary page 1.
- K961029: Kiltex Probe Cover, Kiltex Corp. (1996) Summary page 1.
- K953673: Eclipse Probe Cover, Parker Laboratories, Inc. (1996) Summary page 1.
- K900805: Aloka 500 Diagnostic Ultrasound Scanning System, Ge Medical Systems Information Technologies (1990) Summary page 1.
- K920374: Aloka 650CL Diagnostic Ultrasound System, Ge Medical Systems Information Technologies (1992) Summary page 1.

## Indications for use
Intended to be placed on Ultrasound Probes used in natural body orifices--such as the vagina--to facilitate cleaning and sanitization of the probe.

Source page: https://510kreport.com/device/K974301
Methodology: https://510kreport.com/methodology