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FDA 510(k)

Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)

K-Number: K241451 · 2025-02-11

ApplicantTeleflex Incorporated
Decision Date2025-02-11
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) is a medical device manufactured by Teleflex Incorporated. It received FDA 510(k) clearance on 2025-02-11 under approval number K241451. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)?

Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) is a medical device that received FDA 510(k) clearance on 2025-02-11. It is manufactured by Teleflex Incorporated. The 510(k) number is K241451.

When was Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) approved by the FDA?

Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) received FDA 510(k) clearance on 2025-02-11, under approval number K241451.

What company makes Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)?

Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) is manufactured by Teleflex Incorporated.

What is the FDA product code for Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)?

The FDA product code for Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) is BTR.

Related Clinical Trials

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Related PubMed Literature

PMID: 41515650 Milestone to Ensure Safety and Efficacy of Companion Diagnostic (CDx) That Support Treatment Decisions in Cancer Patients. Diagnostics (Basel, Switzerland) (2026) PMID: 41343216 Describing Inconsistencies in Pediatric Labeling of Medical Devices. JAMA network open (2025) PMID: 40085833 The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR research protocols (2025)

Related Devices (Code: BTR)

K152438ETView VivaSight-SL (TVT) systemEtview , Ltd. K161813Frova Intubating IntroducerWilliam Cook Europe Aps K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. K181880VivaSight-SL (TVT) systemEtview , Ltd. K171917Frova Intubating IntroducerCook Incorporated K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded StyletNevap, Inc.

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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