Cleared Traditional

K802126 - ISOLETTE INCUBATOR C-100

K802126 is an FDA 510(k) clearance for ISOLETTE INCUBATOR C-100, manufactured by Narco Air-Shields. The device is a Class 2 General Hospital device with product code FMZ cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K802126 · Narco Air-Shields · General Hospital
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Sep 1980
Decision
22d
Days
Class 2
Risk

K802126 is an FDA 510(k) clearance for the ISOLETTE INCUBATOR C-100. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Narco Air-Shields (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 22 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Narco Air-Shields devices

FDA 510(k) Submission Details - K802126

510(k) Number K802126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1980
Decision Date September 26, 1980
Days to Decision 22 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 129d · This submission: 22d
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 47
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K802126.
140 NEOCARE AIR CONTROLLED INCUBATOR
K810067 · Vickers America Medical Corp. · Mar 1981
OHIO IC INCUBATOR
K802639 · Ohio Medical Products · Nov 1980
OHIO GC INCUBATOR
K802640 · Ohio Medical Products · Nov 1980
THERMA-SHIELD
K801461 · Olympic Medical Corp. · Jul 1980
ISOLETTE INCUBATOR
K781876 · Air-Shields, Inc. · Dec 1978
INFANT INCUBATOR
K780472 · Air-Shields, Inc. · Apr 1978