Cleared Traditional

K813543 - ADR ULTRASOUND MODELS 4000S & 4000S/L

K813543 is an FDA 510(k) clearance for ADR ULTRASOUND MODELS 4000S & 4000S/L, manufactured by Adr Ultrasound. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K813543 · Adr Ultrasound · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1982
Decision
65d
Days
Class 2
Risk

K813543 is an FDA 510(k) clearance for the ADR ULTRASOUND MODELS 4000S & 4000S/L. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Adr Ultrasound (Mchenry, US). The FDA issued a Cleared decision on February 24, 1982 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Adr Ultrasound devices

FDA 510(k) Submission Details - K813543

510(k) Number K813543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1981
Decision Date February 24, 1982
Days to Decision 65 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 107d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 706
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K813543.
AUTO SECTOR MCU
K813596 · Technicare Corp. · Mar 1982
SINUSCOPE
K812686 · Jedmed Instrument Co. · Mar 1982
INTEGRAL SECTOR MODULE
K820124 · Siemens Gammasonics, Inc. · Mar 1982
DATAPASS
K812435 · General Electric Co. · Jan 1982
IMAGER 2000 REAL TIME SYSTEM
K811842 · Siemens Gammasonics, Inc. · Nov 1981
FETAL VITABILITY TM MODE
K812743 · Technicare Corp. · Nov 1981