Cleared Traditional

K852572 - 3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802

K852572 is an FDA 510(k) clearance for 3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code JAF cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K852572 · Siemens Medical Solutions USA, Inc. · Radiology device
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Sep 1985
Decision
93d
Days
Class 2
Risk

K852572 is an FDA 510(k) clearance for the 3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802. Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on September 19, 1985 after a review of 93 days - within the typical 510(k) review window.

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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K852572

510(k) Number K852572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1985
Decision Date September 19, 1985
Days to Decision 93 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
14d faster than avg
Panel avg: 107d · This submission: 93d
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 21
Devices cleared under the same product code (JAF) and FDA review panel - the closest regulatory comparables to K852572.
HANDHELD DOPLER/PEN TRANSDUCER 3MHZ
K854590 · Philips Medical Systems, Inc. · Apr 1986
SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ
K854591 · Philips Medical Systems, Inc. · Apr 1986
KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1
K851149 · Keymed, Inc. · Nov 1985
EUB-40
K844128 · Hitachi Medical Corp. of America · Feb 1985
HEMACOUNT WRIGHT GIEMSA STAIN PACK
K822602 · Accra Laboratories, Inc. · Sep 1982
VASCULAB BI-DIRECTIONAL DOPPLER, #D10
K800768 · Medasonics, Inc. · Jul 1980