Kendall CO2NFIRM Now CO2 Detector

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K042572 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Palindrome 14.5 Fr Chronic Hemodialysis Catheter

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• Kendall Argyle 2 Fr Double Lumen Neonatal/Pediatric Picc, Model 43304

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  FDA 510(k) K042461 Active Cleared 10 Dec 2004

• Pallindrome 14.5Fr Chronic Hemodialysis Catheter

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• Acute and Chronic Catheter Repair Kit

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• 14.5 Fr Chronic Hemodialysis Catheter with Insertion Stylets Accessory

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• Kedall 14.5 Fr Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby)

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  FDA 510(k) K060972 Active Cleared 4 Aug 2006

See all devices from Kendall →

• What clinical procedures is the Kendall CO₂Confirm Now CO₂ Detector primarily used to verify during endoscopy or related interventions?

  The device is designed to rapidly confirm the presence of carbon dioxide (CO₂) within the gastrointestinal tract during procedures like endoscopy or related interventions in gastroenterology and urology settings. This helps clinicians verify proper placement or patency of tubes, ensuring the procedure is progressing as intended.

• Is the Kendall CO₂Confirm Now CO₂ Detector reusable, or is it intended for single-use only?

  The device is explicitly supplied as a single-use instrument, meaning it is intended for one-time clinical use only. This aligns with standard practices for diagnostic tools to ensure patient safety and prevent cross-contamination.

• How should the Kendall CO₂Confirm Now CO₂ Detector be stored, and what are the key considerations for handling?

  Storage and handling follow standard medical device protocols for single-use diagnostic tools. Since it is non-sterile, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the packaging for expiration dates or integrity before use to ensure accuracy and reliability.

• What regulatory pathway was followed for FDA clearance of the Kendall CO₂Confirm Now CO₂ Detector?

  The device received FDA clearance through a traditional 510(k) process, specifically under clearance number K042572. This pathway was used to demonstrate substantial equivalence to a predicate device, ensuring compliance with FDA regulations under product code KNT (Tubes, Gastrointestinal (and Accessories)).

• Does the Kendall CO₂Confirm Now CO₂ Detector have any special safety considerations, such as MRI compatibility?

  The device does not have any specified MRI safety considerations mentioned in its documentation. This means it is not intended for use in MRI environments, and users should confirm compatibility with their facility’s MRI protocols before use.