Cleared Traditional

K930714 - SONICAID MODEL TEAM FECG IUP

K930714 is an FDA 510(k) clearance for SONICAID MODEL TEAM FECG IUP, manufactured by Oxford Instruments, Plc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEL cleared through the Traditional 510(k) pathway after a 924-day FDA review.

K930714 · Oxford Instruments, Plc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
924d
Days
Class 2
Risk

K930714 is an FDA 510(k) clearance for the SONICAID MODEL TEAM FECG IUP. 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 August 24, 1995 after a review of 924 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.

FDA 510(k) Submission Details - K930714

510(k) Number K930714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1993
Decision Date August 24, 1995
Days to Decision 924 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
763d slower than avg
Panel avg: 161d · This submission: 924d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HEL Monitor, Heart Rate, Fetal, Ultrasonic

Devices cleared under the same product code (HEL) and FDA review panel - the closest regulatory comparables to K930714.
TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
K010920 · Medical Cables, Inc. · Jun 2001
COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
K982651 · Corometrics Medical Systems, Inc. · Dec 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006
K971240 · Alexander Mfg. Co. · Jun 1997
SONICAID MODEL P110 FETAL HEAR DETECTOR
K933816 · Oxford Instruments, Plc. · Dec 1994
K930714 · SONICAID MODEL TEAM FECG IUP
Download PDF Oxford Instruments, P…