Cleared Traditional

K883160 - CATAPULT BUCKY (KATAPULT BLENDA)

K883160 is an FDA 510(k) clearance for CATAPULT BUCKY (KATAPULT BLENDA), manufactured by Bay X-Ray, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K883160 · Bay X-Ray, Inc. · Radiology device
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Sep 1988
Decision
44d
Days
Class 2
Risk

K883160 is an FDA 510(k) clearance for the CATAPULT BUCKY (KATAPULT BLENDA). Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Bay X-Ray, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on September 8, 1988 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Bay X-Ray, Inc. devices

FDA 510(k) Submission Details - K883160

510(k) Number K883160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1988
Decision Date September 08, 1988
Days to Decision 44 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 107d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 297
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K883160.
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