Cleared Special

K022876 - MODIFICATION TO INFANT LIFE SUPPORT MODULE-20

K022876 is an FDA 510(k) clearance for MODIFICATION TO INFANT LIFE SUPPORT MOD..., manufactured by International Biomedical, Inc.. The device is a Class 2 General Hospital device with product code FPL cleared through the Special 510(k) pathway after a 12-day FDA review.

K022876 · International Biomedical, Inc. · General Hospital
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Sep 2002
Decision
12d
Days
Class 2
Risk

K022876 is an FDA 510(k) clearance for the MODIFICATION TO INFANT LIFE SUPPORT MODULE-20. Classified as Incubator, Neonatal Transport (product code FPL), Class II - Special Controls.

Submitted by International Biomedical, Inc. (Austin, US). The FDA issued a Cleared decision on September 11, 2002 after a review of 12 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5410 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all International Biomedical, Inc. devices

FDA 510(k) Submission Details - K022876

510(k) Number K022876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2002
Decision Date September 11, 2002
Days to Decision 12 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 129d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

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 12
Devices cleared under the same product code (FPL) and FDA review panel - the closest regulatory comparables to K022876.
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
AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
K103527 · International Biomedical, Ltd. · Apr 2011
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