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Sun-One Breathing Frequency Monitor

by Ensun Medical Products, Inc.

510(k) K842048

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 NumberK842048 Date1 Nov 1984ClearedStatusActive

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  • Withdrawn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
Sun-One
510(k) Number
FDA Product Code
BZQ
Device Class
Class II
Regulation
21 CFR Part 868.2375
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Sun-One is a Monitor, Breathing Frequency, classified under FDA regulation 868.2375. This device is designed to measure and display the rate of a patient’s respiratory cycles, providing real-time monitoring of breathing frequency—a critical parameter in anesthesia and critical care settings.

Intended for use in clinical environments, the Sun-One is a reusable Class II device with no explicit sterility requirements noted in regulatory filings. It operates in MRI-unsafe settings and is supplied as a standalone unit. The device holds an FDA 510(k) clearance (K842048) under the Anesthesiology advisory committee, with no third-party distribution flag. No additional regulatory markings or certifications are referenced beyond the 510(k) clearance.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Sun-One monitor used for?

    The Sun-One is designed to measure and display a patient’s respiratory rate in real-time. This is particularly useful in anesthesia and critical care settings, where monitoring breathing frequency is essential for assessing a patient’s condition and ensuring proper ventilation support.

  • Is the Sun-One monitor reusable or single-use?

    The Sun-One is a reusable Class II device. Unlike single-use monitors, it is intended for repeated use in clinical environments, provided it is properly maintained and cleaned between uses. No explicit sterility requirements are noted in regulatory filings, but standard infection control practices should be followed.

  • Can the Sun-One monitor be used in MRI environments?

    No, the Sun-One is classified as MRI-unsafe. This means it should not be used in or near MRI machines, as its materials or components could interfere with MRI imaging or pose a risk to patients during the procedure.

  • What regulatory approval does the Sun-One hold?

    The Sun-One holds an FDA 510(k) clearance (K842048) under the Anesthesiology advisory committee. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and meets applicable regulatory requirements for safety and effectiveness in its intended use.

  • How is the Sun-One monitor supplied?

    The Sun-One is supplied as a standalone unit. It does not require additional accessories or components beyond what is included in the package, making it a self-contained solution for respiratory rate monitoring in clinical settings.