Cleared Traditional

K932929 - HRV 4000EM

K932929 is an FDA 510(k) clearance for HRV 4000EM, manufactured by All-Tronics Medical Systems. The device is a Class 2 Radiology device with product code DSH cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K932929 · All-Tronics Medical Systems · Radiology device
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Sep 1993
Decision
86d
Days
Class 2
Risk

K932929 is an FDA 510(k) clearance for the HRV 4000EM. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by All-Tronics Medical Systems (Cleveland, US). The FDA issued a Cleared decision on September 9, 1993 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2800 - 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 All-Tronics Medical Systems devices

FDA 510(k) Submission Details - K932929

510(k) Number K932929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1993
Decision Date September 09, 1993
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 121
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