Cleared Traditional

Babyleo TN500

K251619 · Dr?gerwerk AG & Co KGaA · General Hospital
Feb 2026
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K251619 is an FDA 510(k) clearance for the Babyleo TN500, a Incubator, Neonatal (Class II — Special Controls, product code FMZ), submitted by Dr?gerwerk AG & Co KGaA (Luebeck, DE). The FDA issued a Cleared decision on February 13, 2026, 262 days after receiving the submission on May 27, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number K251619 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2025
Decision Date February 13, 2026
Days to Decision 262 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMZ — Incubator, Neonatal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5400

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