Cleared Traditional

K011840 - CERVILENZ UTERINE MEASURING SOUND

K011840 is an FDA 510(k) clearance for CERVILENZ UTERINE MEASURING SOUND, manufactured by Cervilenz, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HHM cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K011840 · Cervilenz, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
59d
Days
Class 1
Risk

K011840 is an FDA 510(k) clearance for the CERVILENZ UTERINE MEASURING SOUND. Classified as Sound, Uterine (product code HHM), Class I - General Controls.

Submitted by Cervilenz, Inc. (Irvine, US). The FDA issued a Cleared decision on August 10, 2001 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cervilenz, Inc. devices

FDA 510(k) Submission Details - K011840

510(k) Number K011840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2001
Decision Date August 10, 2001
Days to Decision 59 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 160d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

HHM Device Classification - Class 1, General Controls

Product Code HHM Sound, Uterine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HHM Sound, Uterine

Devices cleared under the same product code (HHM) and FDA review panel - the closest regulatory comparables to K011840.
ROCKET INTRAUTERINE DEPTH SOUND
K884684 · A & A Medical, Inc. · Dec 1988
ROCKET INTRAUTERINE SOUND
K883806 · A & A Medical, Inc. · Oct 1988
TEFLON UTERINE SOUND
K870550 · Cook Ob/Gyn · Mar 1987
UTERINE SOUND, BURNETT DISPOSABLE
K781766 · C.R. Bard, Inc. · Dec 1978
INTRAUTERINE SOUND, PLASTIC DISPOSABLE
K760170 · G.D. Searle and Co. · Jul 1976