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FDA 510(k)

ABL90 FLEX PLUS System, safeCLINITUBES

K-Number: K252207 · 2026-04-10

ApplicantRadiometer Medicals Aps
Decision Date2026-04-10
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL90 FLEX PLUS System, safeCLINITUBES is a medical device manufactured by Radiometer Medicals Aps. It received FDA 510(k) clearance on 2026-04-10 under approval number K252207. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABL90 FLEX PLUS System, safeCLINITUBES?

ABL90 FLEX PLUS System, safeCLINITUBES is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by Radiometer Medicals Aps. The 510(k) number is K252207.

When was ABL90 FLEX PLUS System, safeCLINITUBES approved by the FDA?

ABL90 FLEX PLUS System, safeCLINITUBES received FDA 510(k) clearance on 2026-04-10, under approval number K252207.

What company makes ABL90 FLEX PLUS System, safeCLINITUBES?

ABL90 FLEX PLUS System, safeCLINITUBES is manufactured by Radiometer Medicals Aps.

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

The FDA product code for ABL90 FLEX PLUS System, safeCLINITUBES is CHL.

Other Devices by Radiometer Medicals Aps

K240998ABL90 FLEX PLUS System K241037ABL90 FLEX PLUS System K252475ABL90 FLEX PLUS System K252488ABL90 FLEX PLUS System

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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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