Cleared Special

K182859 - Babyleo TN500 (FDA 510(k) Clearance)

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

K182859 · Dragerwerk AG & CO Kgaa · General Hospital
Feb 2019
Decision
134d
Days
Class 2
Risk

K182859 is an FDA 510(k) clearance for the Babyleo TN500. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Dragerwerk AG & CO Kgaa (Lübeck, DE). The FDA issued a Cleared decision on February 22, 2019 after a review of 134 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K182859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2018
Decision Date February 22, 2019
Days to Decision 134 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 169d · This submission: 134d
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.