Cleared Abbreviated

K992811 - TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (FDA 510(k) Clearance)

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K992811 · Epic Medical Equipment Services, Inc. · Radiology device
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Jan 2000
Decision
151d
Days
Class 2
Risk

K992811 is an FDA 510(k) clearance for the TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING. Classified as Monitor, Uterine Contraction, External (for Use In Clinic) (product code HFM), Class II - Special Controls.

Submitted by Epic Medical Equipment Services, Inc. (Plano, US). The FDA issued a Cleared decision on January 18, 2000 after a review of 151 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2720 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Epic Medical Equipment Services, Inc. devices

Submission Details

510(k) Number K992811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1999
Decision Date January 18, 2000
Days to Decision 151 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 107d · This submission: 151d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 Radiology devices follow this clearance model.