Cleared Traditional

K834277 - MOD 427

K834277 is an FDA 510(k) clearance for MOD 427, manufactured by Hoffrel Instruments, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K834277 · Hoffrel Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
109d
Days
Class 2
Risk

K834277 is an FDA 510(k) clearance for the MOD 427. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Hoffrel Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1984 after a review of 109 days - within the typical 510(k) review window.

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: 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 Hoffrel Instruments, Inc. devices

FDA 510(k) Submission Details - K834277

510(k) Number K834277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1983
Decision Date February 17, 1984
Days to Decision 109 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 107d · This submission: 109d
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 666
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K834277.
TECHNICARE 280
K834486 · Technicare Corp. · Apr 1984
CALIBRE-TENTATIVE TRADENAME
K833225 · Advanced Technology Laboratories, Inc. · Feb 1984
SIGMA 20 ELECTRONIC SECTOR SCANNER
K833680 · Kontron Instruments, Inc. · Feb 1984
KC 100 M
K834285 · Elscint, Inc. · Feb 1984
US-1000 ULTRASONIC IMAGING SYSTEM
K832331 · Nidek, Inc. · Aug 1983
OCULAR-BIOMETER 4000
K820042 · Radionics, Inc. · Jul 1982