Cleared Traditional

K862072 - FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01

K862072 is an FDA 510(k) clearance for FETASCAN ULTRASOUND TRANSDUCER IBI# 101..., manufactured by International Biomedics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGL cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K862072 · International Biomedics, Inc. · Obstetrics & Gynecology device
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Jul 1986
Decision
40d
Days
Class 2
Risk

K862072 is an FDA 510(k) clearance for the FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01. Classified as Transducer, Ultrasonic, Obstetric (product code HGL), Class II - Special Controls.

Submitted by International Biomedics, Inc. (Bothell, US). The FDA issued a Cleared decision on July 9, 1986 after a review of 40 days - a notably fast clearance cycle.

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: 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 International Biomedics, Inc. devices

FDA 510(k) Submission Details - K862072

510(k) Number K862072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1986
Decision Date July 09, 1986
Days to Decision 40 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
120d faster than avg
Panel avg: 160d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGL Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (HGL) and FDA review panel - the closest regulatory comparables to K862072.
DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE
K864908 · Diasonics, Inc. · Mar 1987
7.5 MHZ ENDOVAGINAL PROBE
K870709 · Philips Ultrasound, Inc. · Mar 1987
TRANSVAGINAL PROBE, MODEL ED65M-TV
K861371 · Elscint, Inc. · Jul 1986
ACUSON S228, S519 & L558 TRANSDUCERS
K861577 · Acuson Computed Sonography · Jun 1986
ACUSON S328, L382, L538 & L312 TRANSDUCERS
K861578 · Acuson Computed Sonography · Jun 1986
TRANSVAGINAL TRANSDUCER, 5MHZ
K860234 · Philips Medical Systems, Inc. · May 1986