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Respiratory Monitor, Two-Gas, RDC

by Research Development Corp.

510(k) K770785

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770785 Date20 May 1977ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Monitor, Respiratory, Two-Gas, Rdc
510(k) Number
FDA Product Code
KLA
Device Class
Class II
Regulation
21 CFR Part 876.1725
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Monitor, Respiratory, Two-Gas, designed for measuring and displaying two respiratory gases in real-time. It falls under the classification of monitors for esophageal and anorectal motility, though its primary function is respiratory gas analysis, as indicated by its 510(k) submission.

The Respiratory Monitor, Two-Gas, RDC is intended for clinical use in settings requiring precise respiratory gas monitoring. It was cleared under FDA 510(k) K770785 with a Substantially Equivalent (SESE) determination, regulated under 21 CFR 876.1725. No details on sterility, single-use, or MRI safety are provided in the specifications, and no additional context on supply or storage conditions is available.

Other devices from Research Development Corp.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical settings is this respiratory gas monitor primarily intended for and how does it function?

    This device is designed for clinical use in settings where precise real-time monitoring of two respiratory gases is required. It measures and displays those gases continuously, making it suitable for environments like intensive care units, operating rooms, or any clinical area where accurate respiratory gas analysis is critical. The monitor was cleared under FDA 510(k) K770785, indicating its regulatory approval for use in these contexts.

  • Is this device single-use or reusable, and what are the storage requirements?

    The specifications for this device do not explicitly state whether it is single-use or reusable. Additionally, no details regarding storage conditions (such as temperature, humidity, or shelf life) are provided in the available data. Users should refer to the manufacturer’s instructions for proper storage and handling.

  • What sizes or models of this respiratory monitor are available, and how are they differentiated?

    The provided data does not specify any variations in sizes, models, or differentiated features for this device. It is listed as a single entry under the name *Monitor, Respiratory, Two-Gas, RDC*, so no additional configurations or variants are mentioned.

  • How was this device’s regulatory approval determined, and what does that mean for its use?

    This device was cleared under the FDA’s 510(k) process with a *Substantially Equivalent (SESE)* determination, meaning it was found to be as safe and effective as a legally marketed device that served as its predicate. This classification falls under 21 CFR 876.1725, indicating its regulatory pathway was traditional clearance. Clinically, this means it meets FDA standards for respiratory gas monitoring as intended.