Cleared Traditional

K121929 - ZEPHYR 'X-SERIES PATIENT TRANSFER SLED

K121929 is an FDA 510(k) clearance for ZEPHYR 'X-SERIES PATIENT TRANSFER SLED, manufactured by Diacor, Inc.. The device is a Class 2 Radiology device with product code FRZ cleared through the Traditional 510(k) pathway after a 199-day FDA review.

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

FDA 510(k) Submission Details - K121929

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
Combination Product No
PCCP Authorized No
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.

FRZ Device Classification - Class 2, Special Controls

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.