Cleared Traditional

K854591 - SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ

K854591 is an FDA 510(k) clearance for SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ, manufactured by Philips Medical Systems, Inc.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K854591

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.

JAF Device Classification - Class 2, Special Controls

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

All 23
Devices cleared under the same product code (JAF) and FDA review panel - the closest regulatory comparables to K854591.
MULTI DOPPLEX, MD-1
K900882 · Huntleigh Technology, Inc. · Aug 1990
MEDACORD PVL, PERSONAL VASCULAR LABORATORY
K882018 · Medasonics, Inc. · Sep 1988
HANDHELD DOPLER/PEN TRANSDUCER 3MHZ
K854590 · Philips Medical Systems, Inc. · Apr 1986
KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1
K851149 · Keymed, Inc. · Nov 1985
3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802
K852572 · Siemens Medical Solutions USA, Inc. · Sep 1985
EUB-40
K844128 · Hitachi Medical Corp. of America · Feb 1985