Cleared Traditional

1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507 (K860621) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K860621 · Impex Medical Systems, Inc. · Obstetrics & Gynecology device
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May 1986
Decision
90d
Days
Class 2
Risk

K860621 is an FDA 510(k) clearance for the 1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507. Classified as Transducer, Ultrasonic, Obstetric (product code HGL), Class II - Special Controls.

Submitted by Impex Medical Systems, Inc. (Golden, US). The FDA issued a Cleared decision on May 20, 1986 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2960 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Impex Medical Systems, Inc. devices

Submission Details

510(k) Number K860621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1986
Decision Date May 20, 1986
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGL Transducer, Ultrasonic, Obstetric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2960
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGL Transducer, Ultrasonic, Obstetric

All 35
Devices cleared under the same product code (HGL) and FDA review panel - the closest regulatory comparables to K860621.
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
K895026 · Hewlett-Packard Co. · Nov 1989
SIEMENS INTRAVAGINAL TRANSDUCER
K881405 · Siemens Medical Solutions USA, Inc. · Aug 1988
3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031
K860313 · Johnson & Johnson Professionals, Inc. · Mar 1986
ARTIUS SYSTEM
K771151 · General Electric Co. · Aug 1977