Cleared Traditional

K821896 - C-300 INFANT INCUBATOR

K821896 is an FDA 510(k) clearance for C-300 INFANT INCUBATOR, manufactured by Narco Scientific. The device is a Class 2 General Hospital device with product code FMZ cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K821896 · Narco Scientific · General Hospital
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Jul 1982
Decision
30d
Days
Class 2
Risk

K821896 is an FDA 510(k) clearance for the C-300 INFANT INCUBATOR. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Narco Scientific (Mchenry, US). The FDA issued a Cleared decision on July 28, 1982 after a review of 30 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 Scientific devices

FDA 510(k) Submission Details - K821896

510(k) Number K821896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1982
Decision Date July 28, 1982
Days to Decision 30 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
99d faster than avg
Panel avg: 129d · This submission: 30d
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 K821896.
AMEDA AMELETTE(R) NEONATAL INCUBATOR
K870223 · Hollister, Inc. · Jun 1987
OHIO(R) CARE PLUS INCUBATOR
K871399 · Ohmeda Medical · Jun 1987
C-200 INFANT INCUBATOR
K822656 · Narco Scientific · Oct 1982
OXYGENAIRE NURING INCUBATOR
K813239 · Vickers America Medical Corp. · Jan 1982
NEOCARE BABY-CONTROLLED INCUBATOR
K813238 · Vickers America Medical Corp. · Jan 1982
NEOCARE TEMPERATURE MONITOR
K810792 · Vickers America Medical Corp. · Apr 1981