Cleared Traditional

K161918 - SREE MRI Transport Incubator (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161918 · Advanced Imaging Research Dba Sree Medical Systems · General Hospital
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Mar 2017
Decision
233d
Days
Class 2
Risk

K161918 is an FDA 510(k) clearance for the SREE MRI Transport Incubator. Classified as Incubator, Neonatal Transport (product code FPL), Class II - Special Controls.

Submitted by Advanced Imaging Research Dba Sree Medical Systems (Cleveland, US). The FDA issued a Cleared decision on March 3, 2017 after a review of 233 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5410 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Imaging Research Dba Sree Medical Systems devices

Submission Details

510(k) Number K161918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2016
Decision Date March 03, 2017
Days to Decision 233 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 128d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPL Incubator, Neonatal Transport
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5410
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 General Hospital devices follow this clearance model.