Cleared Traditional

K172154 - Isolette 8000 plus

K172154 is an FDA 510(k) clearance for Isolette 8000 plus, manufactured by Draeger Medical Sytems, Inc.. The device is a Class 2 General Hospital device with product code FMZ cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K172154 · Draeger Medical Sytems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
276d
Days
Class 2
Risk

K172154 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 Sytems, Inc. (Telford, US). The FDA issued a Cleared decision on April 19, 2018 after a review of 276 days - an extended review 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: 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 Draeger Medical Sytems, Inc. devices

FDA 510(k) Submission Details - K172154

510(k) Number K172154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2017
Decision Date April 19, 2018
Days to Decision 276 days
Submission Type Traditional
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
147d slower than avg
Panel avg: 129d · This submission: 276d
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 46
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K172154.
Infant Incubator
K190494 · Ningbo David Medical Device Co., Ltd. · Nov 2019
Babyleo TN500
K182859 · Dragerwerk AG & CO Kgaa · Feb 2019
Isolette 8000 Plus
K182977 · Draeger Medical Systems, Inc. · Nov 2018
GIRAFFE INCUBATOR
K101778 · Ohmeda Medical · Jul 2010
GIRAFFE OMNIBED
K101788 · Ohmeda Medical · Jul 2010
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
K072512 · Datex-Ohmeda, Inc. · Oct 2007