Cleared Traditional

K912626 - BOLUS XENON CIRCUIT

K912626 is the FDA 510(k) clearance for BOLUS XENON CIRCUIT by Vital Signs, Inc.. It is a Class 2 Radiology device (product code IYT) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K912626 · Vital Signs, Inc. · Radiology device
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Aug 1991
Decision
50d
Days
Class 2
Risk

K912626 is an FDA 510(k) clearance for the BOLUS XENON CIRCUIT. Classified as System, Rebreathing, Radionuclide (product code IYT), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on August 2, 1991 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1390 - 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 Vital Signs, Inc. devices

Submission Details

510(k) Number K912626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1991
Decision Date August 02, 1991
Days to Decision 50 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 107d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYT System, Rebreathing, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1390
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 - IYT System, Rebreathing, Radionuclide

All 29
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