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VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O - Ventiplus Disposable Manometer 0

by A Plus Medical 510(k)

Active United States

510(k) K102377

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK102377 Date18 Nov 2010ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CAP
Models / Variants
Ventiplus Disposable Manometer 0
Device Class
Class II
Regulation
21 CFR Part 868.2600
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Ventiplus Disposable Manometer is a mechanical pressure monitoring device that measures airway pressure using linear spring compression proportional to gas pressure. It is available in pressure ranges of 0-60 cm H2O and 0-20 cm H2O, with a disposable housing featuring graduated markings for easy reading. This device contains no electronic components, software, or requires an external energy source.

The Ventiplus Disposable Manometer is designed for single patient use and is intended for monitoring airway pressure in clinical settings. It is regulated under FDA 510(k) clearance with product code CAP and is classified as a Monitor, Airway Pressure (includes Gauge And/or Alarm) under regulation 868.2600. The device is supplied in disposable form and requires appropriate storage conditions as specified by the manufacturer.

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