Cleared Traditional

K954847 - DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES

K954847 is an FDA 510(k) clearance for DISCO UTERINE CONTRACTION TRANSDUCER & ..., manufactured by Ocg Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFM cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K954847 · Ocg Systems, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
212d
Days
Class 2
Risk

K954847 is an FDA 510(k) clearance for the DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES. Classified as Monitor, Uterine Contraction, External (for Use In Clinic) (product code HFM), Class II - Special Controls.

Submitted by Ocg Systems, Inc. (Highland Park, US). The FDA issued a Cleared decision on May 22, 1996 after a review of 212 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2720 - 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 Ocg Systems, Inc. devices

FDA 510(k) Submission Details - K954847

510(k) Number K954847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1995
Decision Date May 22, 1996
Days to Decision 212 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 160d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFM Device Classification - Class 2, Special Controls

Product Code HFM Monitor, Uterine Contraction, External (for Use In Clinic)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2720
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 - HFM Monitor, Uterine Contraction, External (for Use In Clinic)

All 9
Devices cleared under the same product code (HFM) and FDA review panel - the closest regulatory comparables to K954847.
KOALA TOCO
K140163 · Clinical Innovations, LLC · May 2014
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
K994353 · Precision Dynamics Corp. · Mar 2000
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
K992811 · Epic Medical Equipment Services, Inc. · Jan 2000
BUBBLE TOCO
K920152 · Utah Medical Products, Inc. · May 1993
MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER
K910282 · Graphic Controls Corp. · Mar 1991
MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR
K894030 · Healthdyne, Inc. · Jan 1990