Cleared Traditional

K914864 - MODELS C500/C550 ISOLETE INFANT INCUBATOR

K914864 is an FDA 510(k) clearance for MODELS C500/C550 ISOLETE INFANT INCUBATOR, manufactured by Air-Shields, Inc.. The device is a Class 2 General Hospital device with product code FMZ cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K914864 · Air-Shields, Inc. · General Hospital
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Mar 1992
Decision
136d
Days
Class 2
Risk

K914864 is an FDA 510(k) clearance for the MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Air-Shields, Inc. (Hatboro, US). The FDA issued a Cleared decision on March 13, 1992 after a review of 136 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5400 - 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 Air-Shields, Inc. devices

FDA 510(k) Submission Details - K914864

510(k) Number K914864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1991
Decision Date March 13, 1992
Days to Decision 136 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 129d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMZ Device Classification - Class 2, Special Controls

Product Code FMZ Incubator, Neonatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5400
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 - FMZ Incubator, Neonatal

All 41
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K914864.
C450/C400 INFANT INCUBATORS
K940975 · Air-Shields, Inc. · Jun 1994
ISOLETTE INCUBATOR HUMIDITY METER
K924170 · Air-Shields, Inc. · Feb 1993
TYPE INTERFACE 9271/1 INCUBATOR/WARMER
K912000 · S & W Medico Teknik · Sep 1992
OHIO CARE PLUS INCUBATOR
K914487 · Ohmeda Medical · Dec 1991
MODEL C386 ISOLETTE(R) INFANT INCUBATOR
K913291 · Air-Shields, Inc. · Nov 1991
OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION
K913154 · Ohmeda Medical · Sep 1991