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FDA 510(k)

ABL90 FLEX PLUS System

K-Number: K252475 · 2026-05-01

ApplicantRadiometer Medicals Aps
Decision Date2026-05-01
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL90 FLEX PLUS System is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medicals Aps. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K252475. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABL90 FLEX PLUS System?

ABL90 FLEX PLUS System is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Radiometer Medicals Aps. The 510(k) number is K252475.

When did ABL90 FLEX PLUS System receive FDA 510(k) clearance?

ABL90 FLEX PLUS System received FDA 510(k) clearance on 2026-05-01, under 510(k) number K252475.

Who is the listed applicant for ABL90 FLEX PLUS System?

The FDA 510(k) record lists Radiometer Medicals Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABL90 FLEX PLUS System?

The FDA product code for ABL90 FLEX PLUS System is JGS.

Other records listing Radiometer Medicals Aps 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.

K252488ABL90 FLEX PLUS SystemK252207ABL90 FLEX PLUS System, safeCLINITUBESK241037ABL90 FLEX PLUS SystemK240998ABL90 FLEX PLUS System

Related Devices (Code: JGS)

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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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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