FDA 510(k)

インスタTRUE スチーム用即時生物学的指標（IBI-05）

K番号: K251559 · 2026-06-18

決定日2026-06-18

製品コードQVB

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

InstaTRU Instant Biological Indicator for Steam (IBI-05) is the device name listed in this FDA 510(k) record. The listed applicant is True Indicating, LLC. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K251559. The device is classified under product code QVB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the InstaTRU Instant Biological Indicator for Steam (IBI-05)?

InstaTRU Instant Biological Indicator for Steam (IBI-05) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is True Indicating, LLC. The 510(k) number is K251559.

When did InstaTRU Instant Biological Indicator for Steam (IBI-05) receive FDA 510(k) clearance?

InstaTRU Instant Biological Indicator for Steam (IBI-05) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K251559.

Who is the listed applicant for InstaTRU Instant Biological Indicator for Steam (IBI-05)?

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

What is the FDA product code for InstaTRU Instant Biological Indicator for Steam (IBI-05)?

The FDA product code for InstaTRU Instant Biological Indicator for Steam (IBI-05) is QVB.

申請者としてTrue Indicating, LLCを記載するその他の記録

K242860蒸気（CSPN-15）用統合インジケーター Type 5 K233413ウルトラフォン化学指示器（TRO-TおよびTRO-B）K220778蒸気用化学指示器 K210481即時20秒インディケーター K200970自立型生物指標

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