Cleared Traditional

K220742 - NxtGen Infant Transport Incubator

K220742 is an FDA 510(k) clearance for NxtGen Infant Transport Incubator, manufactured by International Biomedical. The device is a Class 2 General Hospital device with product code FPL cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K220742 · International Biomedical · General Hospital
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Jul 2022
Decision
123d
Days
Class 2
Risk

K220742 is an FDA 510(k) clearance for the NxtGen Infant Transport Incubator. Classified as Incubator, Neonatal Transport (product code FPL), Class II - Special Controls.

Submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on July 15, 2022 after a review of 123 days - within the typical 510(k) review window.

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 International Biomedical devices

FDA 510(k) Submission Details - K220742

510(k) Number K220742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2022
Decision Date July 15, 2022
Days to Decision 123 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 129d · This submission: 123d
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 16
Devices cleared under the same product code (FPL) and FDA review panel - the closest regulatory comparables to K220742.
SREE MRI Transport Incubator
K161918 · Advanced Imaging Research Dba Sree Medical Systems · Mar 2017
GLOBE-TROTTER GT5400
K141565 · Draeger Medical Systems, Inc. · Sep 2014
ATOM TRANSCAPSULE V-707
K123937 · Atom Medical Corporation · May 2013
185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
K103523 · International Biomedical, Ltd. · May 2011
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
K103525 · International Biomedical, Ltd. · May 2011
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
K103524 · International Biomedical, Ltd. · Apr 2011