Cleared Traditional

K854591 - SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ

K854591 is the FDA 510(k) clearance for SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ by Philips Medical Systems, Inc.. It is a Class 2 Radiology device (product code JAF) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K854591 · Philips Medical Systems, Inc. · Radiology device
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Apr 1986
Decision
156d
Days
Class 2
Risk

K854591 is an FDA 510(k) clearance for the SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ. Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (Santa Ana, US). The FDA issued a Cleared decision on April 23, 1986 after a review of 156 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1540 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medical Systems, Inc. devices

Submission Details

510(k) Number K854591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date April 23, 1986
Days to Decision 156 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 107d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAF Monitor, Ultrasonic, Nonfetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1540
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.

Regulatory Peers - JAF Monitor, Ultrasonic, Nonfetal

Devices cleared under the same product code (JAF) and FDA review panel - the closest regulatory comparables to K854591.
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HANDHELD DOPLER/PEN TRANSDUCER 3MHZ
K854590 · Philips Medical Systems, Inc. · Apr 1986
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EUB-40
K844128 · Hitachi Medical Corp. of America · Feb 1985