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FDA 510(k)

Babyleo TN500

K-Number: K251619 · 2026-02-13

ApplicantDrägerwerk AG & Co. KGaA
Decision Date2026-02-13
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Babyleo TN500 is the device name listed in this FDA 510(k) record. The listed applicant is Drägerwerk AG & Co. KGaA. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K251619. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Babyleo TN500?

Babyleo TN500 is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Drägerwerk AG & Co. KGaA. The 510(k) number is K251619.

When did Babyleo TN500 receive FDA 510(k) clearance?

Babyleo TN500 received FDA 510(k) clearance on 2026-02-13, under 510(k) number K251619.

Who is the listed applicant for Babyleo TN500?

The FDA 510(k) record lists Drägerwerk AG & Co. KGaA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Babyleo TN500?

The FDA product code for Babyleo TN500 is FMZ.

Other records listing Drägerwerk AG & Co. KGaA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FMZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc.K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.K243437mOm Essential Incubator (ME1)Mom Incubators LimitedK213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.K190494Infant IncubatorNingbo David Medical Device Co., Ltd.K182859Babyleo TN500Dragerwerk AG & CO Kgaa

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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