Cleared Traditional

K900271 - MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK

K900271 is an FDA 510(k) clearance for MODEL OB-500 FETAL GROWTH ANALYSIS & OP..., manufactured by Digisonics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEM cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K900271 · Digisonics, Inc. · Obstetrics & Gynecology device
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Apr 1990
Decision
90d
Days
Class 2
Risk

K900271 is an FDA 510(k) clearance for the MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK. Classified as Imager, Ultrasonic Obstetric-gynecologic (product code HEM), Class II - Special Controls.

Submitted by Digisonics, Inc. (Houston, US). The FDA issued a Cleared decision on April 19, 1990 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 884.2225 - 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 Digisonics, Inc. devices

FDA 510(k) Submission Details - K900271

510(k) Number K900271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1990
Decision Date April 19, 1990
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.

HEM Device Classification - Class 2, Special Controls

Product Code HEM Imager, Ultrasonic Obstetric-gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2225
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 - HEM Imager, Ultrasonic Obstetric-gynecologic

All 18
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