Cleared Special

Isolette 8000 Plus (K182977) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K182977 · Draeger Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
26d
Days
Class 2
Risk

K182977 is an FDA 510(k) clearance for the Isolette 8000 Plus. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on November 21, 2018 after a review of 26 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. 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 Draeger Medical Systems, Inc. devices

Submission Details

510(k) Number K182977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2018
Decision Date November 21, 2018
Days to Decision 26 days
Submission Type Special
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
103d faster than avg
Panel avg: 129d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 8
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K182977.
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K190494 · Ningbo David Medical Device Co., Ltd. · Nov 2019
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K182859 · Dragerwerk AG & CO Kgaa · Feb 2019
Isolette 8000 plus
K172154 · Draeger Medical Sytems, Inc. · Apr 2018
OHMEDA MEDICAL GIRAFFE OMNIBED
K071175 · Ge Healthcare · Jul 2007