Cleared Traditional

K935209 - INSTA-FLO

K935209 is the FDA 510(k) clearance for INSTA-FLO by Medtec, Inc.. It is a Class 2 Radiology device (product code JAD) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K935209 · Medtec, Inc. · Radiology device
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Dec 1993
Decision
45d
Days
Class 2
Risk

K935209 is an FDA 510(k) clearance for the INSTA-FLO. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on December 13, 1993 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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 Medtec, Inc. devices

Submission Details

510(k) Number K935209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1993
Decision Date December 13, 1993
Days to Decision 45 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
62d faster than avg
Panel avg: 107d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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 - JAD System, Therapeutic, X-ray

All 13
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