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CARE2 MEDICAL NEBULIZER - 101

by Steve Islava

510(k) K091794

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 NumberK091794 Date28 Jan 2010ClearedStatusActive

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  • Withdrawn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
CAF
Models / Variants
101
Device Class
Class II
Regulation
21 CFR Part 868.5630
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 Care2 Medical Nebulizer, Model 101/102, 201/202, is a pneumatic nebulizer designed to aerosolize physician-prescribed inhalation solutions. It converts liquid medications into fine mist for inhalation therapy, suitable for infant, pediatric, and adult patients. This device operates by compressing air to disperse medication particles efficiently, facilitating respiratory treatment in clinical settings.

The Care2 Medical Nebulizer is intended for use in healthcare environments where inhalation therapy is administered by physicians or healthcare professionals. Supplied as a reusable device, it requires proper cleaning and maintenance between uses. The device holds an FDA 510(k) clearance under the traditional review pathway, classified under product code CAF and reviewed by the Anesthesiology Advisory Committee. Models 101/102 and 201/202 are distinct variants of the same device.