Cleared Traditional

K912033 - ULTRASOUND STETHOSCOPE(R) INTRADOP(R)

K912033 is an FDA 510(k) clearance for ULTRASOUND STETHOSCOPE INTRADOP, manufactured by Medadonics, Inc.. The device is a Class 2 Radiology device with product code JAF cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K912033 · Medadonics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
159d
Days
Class 2
Risk

K912033 is an FDA 510(k) clearance for the ULTRASOUND STETHOSCOPE(R) INTRADOP(R). Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Medadonics, Inc. (Fremont, US). The FDA issued a Cleared decision on October 15, 1991 after a review of 159 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 Medadonics, Inc. devices

FDA 510(k) Submission Details - K912033

510(k) Number K912033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1991
Decision Date October 15, 1991
Days to Decision 159 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 107d · This submission: 159d
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 27
Devices cleared under the same product code (JAF) and FDA review panel - the closest regulatory comparables to K912033.
IMWXDOP IR
K944196 · Imex Medical Systems, Inc. · May 1995
R AND D BATTERIES
K935427 · R & D Batteries, Inc. · Oct 1994
IMEXDOP CT+
K942441 · Imex Medical Systems, Inc. · Aug 1994
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