Cleared Traditional

SONICAID MODEL P110 FETAL HEAR DETECTOR (K933816) - FDA 510(k) Clearance

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

K933816 · Oxford Instruments, Plc. · Obstetrics & Gynecology device
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Dec 1994
Decision
505d
Days
Class 2
Risk

K933816 is an FDA 510(k) clearance for the SONICAID MODEL P110 FETAL HEAR DETECTOR. Classified as Monitor, Heart Rate, Fetal, Ultrasonic (product code HEL), Class II - Special Controls.

Submitted by Oxford Instruments, Plc. (Clearwater, US). The FDA issued a Cleared decision on December 22, 1994 after a review of 505 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2660 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

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Submission Details

510(k) Number K933816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1993
Decision Date December 22, 1994
Days to Decision 505 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
345d slower than avg
Panel avg: 160d · This submission: 505d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HEL Monitor, Heart Rate, Fetal, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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.