Cleared Traditional

K103215 - CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT

K103215 is an FDA 510(k) clearance for CIANNA S1, manufactured by Cianna Medical. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K103215 · Cianna Medical · Radiology device
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Nov 2010
Decision
14d
Days
Class 2
Risk

K103215 is an FDA 510(k) clearance for the CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Cianna Medical (Aliso Viejo, US). The FDA issued a Cleared decision on November 15, 2010 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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 Cianna Medical devices

FDA 510(k) Submission Details - K103215

510(k) Number K103215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2010
Decision Date November 15, 2010
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

JAQ Device Classification - Class 2, Special Controls

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 - JAQ System, Applicator, Radionuclide, Remote-controlled

All 132
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