Cleared Traditional

K771869 - DIAG. ULTRASOUND B-SCANNER

K771869 is an FDA 510(k) clearance for DIAG. ULTRASOUND B-SCANNER, manufactured by Accusonics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGL cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K771869 · Accusonics, Inc. · Obstetrics & Gynecology device
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Nov 1977
Decision
30d
Days
Class 2
Risk

K771869 is an FDA 510(k) clearance for the DIAG. ULTRASOUND B-SCANNER. Classified as Transducer, Ultrasonic, Obstetric (product code HGL), Class II - Special Controls.

Submitted by Accusonics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1977 after a review of 30 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.

FDA 510(k) Submission Details - K771869

510(k) Number K771869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1977
Decision Date November 02, 1977
Days to Decision 30 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 161d · This submission: 30d
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 35
Devices cleared under the same product code (HGL) and FDA review panel - the closest regulatory comparables to K771869.
1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507
K860621 · Impex Medical Systems, Inc. · May 1986
3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031
K860313 · Johnson & Johnson Professionals, Inc. · Mar 1986
BIO-DERM COUPLING LOTION
K827885 · Whs Products, Inc. · Jan 1982
ARTIUS SYSTEM
K771151 · General Electric Co. · Aug 1977
K771869 · DIAG. ULTRASOUND B-SCANNER
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