Cleared Traditional

K121929 - ZEPHYR 'X-SERIES PATIENT TRANSFER SLED (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121929 · Diacor, Inc. · Radiology device
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Jan 2013
Decision
199d
Days
Class 2
Risk

K121929 is an FDA 510(k) clearance for the ZEPHYR 'X-SERIES PATIENT TRANSFER SLED. Classified as Device, Patient Transfer, Powered (product code FRZ), Class II - Special Controls.

Submitted by Diacor, Inc. (West Valley City, US). The FDA issued a Cleared decision on January 17, 2013 after a review of 199 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 880.6775 - 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 Diacor, Inc. devices

Submission Details

510(k) Number K121929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2012
Decision Date January 17, 2013
Days to Decision 199 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 107d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRZ Device, Patient Transfer, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6775
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.