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FDA 510(k)

Klär Lite (RCW-KL1000)

K-Number: K253871 · 2026-03-04

ApplicantRadcliffe Watts, LLC
Decision Date2026-03-04
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Klär Lite (RCW-KL1000) is the device name listed in this FDA 510(k) record. The listed applicant is Radcliffe Watts, LLC. It received FDA 510(k) clearance on 2026-03-04 under 510(k) number K253871. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Klär Lite (RCW-KL1000)?

Klär Lite (RCW-KL1000) is a medical device that received FDA 510(k) clearance on 2026-03-04. The listed applicant is Radcliffe Watts, LLC. The 510(k) number is K253871.

When did Klär Lite (RCW-KL1000) receive FDA 510(k) clearance?

Klär Lite (RCW-KL1000) received FDA 510(k) clearance on 2026-03-04, under 510(k) number K253871.

Who is the listed applicant for Klär Lite (RCW-KL1000)?

The FDA 510(k) record lists Radcliffe Watts, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Klär Lite (RCW-KL1000)?

The FDA product code for Klär Lite (RCW-KL1000) is FTC.

Related Devices (Code: FTC)

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

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

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