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LPA-2 Remote Alarm

by Life Products, Inc.

510(k) K851905

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 NumberK851905 Date8 Jul 1985ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
CAP
Device Class
Class II
Regulation
21 CFR Part 868.2600
Advisory Committee
Anesthesiology
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.

The LPA-2 Remote Alarm is a Monitor, Airway Pressure (Includes Gauge and/or Alarm), designed to alert clinicians to changes in airway pressure during anesthesia procedures. It functions as an independent alarm system to detect deviations in airway pressure, ensuring patient safety by providing audible and visual alerts when thresholds are exceeded.

This device is intended for use in anesthesia settings, supplied as a reusable medical instrument. It operates independently of primary anesthesia machines and is regulated under FDA 510(k) clearance (K851905) with a classification under regulation 868.2600. No specific sterility or MRI safety information is provided in the specifications, and its design aligns with traditional alarm-based monitoring systems for airway pressure management.

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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 is the primary purpose of the LPA-2 Remote Alarm in anesthesia procedures?

    The LPA-2 Remote Alarm is designed to independently monitor and alert clinicians to changes in airway pressure during anesthesia. It functions as an auxiliary alarm system, providing audible and visual alerts when pressure thresholds are exceeded, ensuring patient safety by complementing primary anesthesia machine monitoring.

  • Is the LPA-2 Remote Alarm intended for single-use or reusable applications?

    The LPA-2 Remote Alarm is supplied as a reusable medical instrument, meaning it is built for repeated use in clinical settings after proper cleaning and maintenance. There is no mention of sterility requirements in the specifications, so adherence to manufacturer guidelines for reprocessing is essential.

  • How is the regulatory status of the LPA-2 Remote Alarm determined?

    The LPA-2 Remote Alarm holds FDA 510(k) clearance (K851905) under regulation 868.2600, classified as a traditional submission. It was determined to be substantially equivalent to a predicate device by the Anesthesiology Advisory Committee in 1985, ensuring compliance with U.S. medical device regulations for airway pressure monitoring.

  • Does the LPA-2 Remote Alarm require any special handling or storage conditions?

    The specifications do not explicitly detail storage conditions or special handling requirements for the LPA-2 Remote Alarm. However, as a reusable device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain functionality and ensure longevity.