Cleared Traditional

K161918 - SREE MRI Transport Incubator

K161918 is an FDA 510(k) clearance for SREE MRI Transport Incubator, manufactured by Advanced Imaging Research Dba Sree Medical Systems. The device is a Class 2 General Hospital device with product code FPL cleared through the Traditional 510(k) pathway after a 233-day FDA review.

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

FDA 510(k) Submission Details - K161918

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
104d slower than avg
Panel avg: 129d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FPL Incubator, Neonatal Transport

All 7
Devices cleared under the same product code (FPL) and FDA review panel - the closest regulatory comparables to K161918.
NxtGen Infant Transport Incubator
K220742 · International Biomedical · Jul 2022
GLOBE-TROTTER GT5400
K141565 · Draeger Medical Systems, Inc. · Sep 2014
MODEL TI500 ISOLETTE INFANT INCUBATOR
K941106 · Air-Shields, Inc. · Jun 1994
TI-1000 TRANSPORT INCUBATOR
K831028 · Narco Scientific · May 1983
REVISED BATTERY CHARGER
K790689 · Vickers America Medical Corp. · May 1979
TRANSPORT INCUBATOR
K790551 · Narco Air-Shields · Apr 1979