# K011840: Cervilenz Uterine Measuring Sound

- Pathway: 510(k) (Traditional)
- Applicant: Cervilenz, Inc.
- Decided: Aug 10, 2001 after 59 days
- Product code: HHM (Sound, Uterine)
- Device class: 1
- Regulation: 21 CFR 884.4530
- 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 K760170 (1976). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870550: Teflon Uterine Sound, Cook Ob/Gyn (1987) Summary page 1.
- K760170: Intrauterine Sound, Plastic Disposable, G.D. Searle and Co. (1976) Summary page 1.

## Indications for use
The Cervilenz Measuring Sound is used for measuring the depth and/or length of the uterus, cervix and vagina.

Source page: https://510kreport.com/device/K011840
Methodology: https://510kreport.com/methodology