Cleared Traditional

K952579 - TOCO TRANSDUCER

K952579 is an FDA 510(k) clearance for TOCO TRANSDUCER, manufactured by Scientific Device Manufacturer, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HFM cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K952579 · Scientific Device Manufacturer, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
60d
Days
Class 2
Risk

K952579 is an FDA 510(k) clearance for the TOCO TRANSDUCER. Classified as Monitor, Uterine Contraction, External (for Use In Clinic) (product code HFM), Class II - Special Controls.

Submitted by Scientific Device Manufacturer, LLC (San Rafael, US). The FDA issued a Cleared decision on August 4, 1995 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scientific Device Manufacturer, LLC devices

FDA 510(k) Submission Details - K952579

510(k) Number K952579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1995
Decision Date August 04, 1995
Days to Decision 60 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 160d · This submission: 60d
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 10
Devices cleared under the same product code (HFM) and FDA review panel - the closest regulatory comparables to K952579.
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
DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
K954847 · Ocg Systems, Inc. · May 1996
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