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FDA 510(k)

K-SHIELD Zen

K-Number: K220799 · 2022-08-29

ApplicantSb-Kawasumi Laboratories, Inc.
Decision Date2022-08-29
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

K-SHIELD Zen is the device name listed in this FDA 510(k) record. The listed applicant is Sb-Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2022-08-29 under 510(k) number K220799. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-SHIELD Zen?

K-SHIELD Zen is a medical device that received FDA 510(k) clearance on 2022-08-29. The listed applicant is Sb-Kawasumi Laboratories, Inc.. The 510(k) number is K220799.

When did K-SHIELD Zen receive FDA 510(k) clearance?

K-SHIELD Zen received FDA 510(k) clearance on 2022-08-29, under 510(k) number K220799.

Who is the listed applicant for K-SHIELD Zen?

The FDA 510(k) record lists Sb-Kawasumi Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-SHIELD Zen?

The FDA product code for K-SHIELD Zen is JKA.

Other records listing Sb-Kawasumi Laboratories, Inc. 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.

K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingK241855SB Knife Jr2 (MD-47702 and MD-47702L)K230408K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)K223810Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

Related Devices (Code: JKA)

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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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