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FDA 510(k)

Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)

K-Number: K252746 · 2026-05-21

ApplicantDrägerwerk AG Co. Kgaa
Decision Date2026-05-21
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) 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 2026-05-21 under 510(k) number K252746. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)?

Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Drägerwerk AG Co. Kgaa. The 510(k) number is K252746.

When did Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) receive FDA 510(k) clearance?

Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) received FDA 510(k) clearance on 2026-05-21, under 510(k) number K252746.

Who is the listed applicant for Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)?

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 Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)?

The FDA product code for Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) is BSZ.

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.

K251619Babyleo TN500K252827IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)K230931AtlanK221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus

Related Devices (Code: BSZ)

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.

K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)Codonics.IncorporatedK230931AtlanDrägerwerk AG Co. KgaaK213867Carestation 750/750cDatex-Ohmeda, Inc.K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB

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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