Panels › Anesthesiology › Product code CAF · Class 2
Nebulizer (Direct Patient Interface)
Regulation 868.5630
4510(k)s in 12 months (509 all time)
0recalls in 12 months (36 all time)
25recalls that name a 510(k)
Top companies in CAF
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2023 | MEDLINE INDUSTRIES, LP - Northfield HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U Open, Classified |
CAF | K142153 |
| Mar 31, 2021 | Smiths Medical ASD Inc. ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients. Terminated |
CAF | K961973 |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Medline Prefilled 550 ml Sterile Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex 5ml Normal Saline (0.9%) Unit Dose Terminated |
CAF | K820227 |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex Unit Dose 15 ml Normal Saline Terminated |
CAF | K820227 |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex Unit Dose 5 ml Normal Saline (0.9%) Terminated |
CAF | K820227 |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Medline Prefilled 350 ml Sterile Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt. Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Intermed 550 ml Sterile Water Humidifier w/5psi Adapt. Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex 550 ml Sterile Water Humidifier w/5psi Adapt. Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Intermed 350 ml Sterile Water Humidifier w/5psi Adapt. Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex 500 ml Sterile Water USP Pour Bottle Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex 1000 ml Sterile Water USP Pour Bottle Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex 550 ml Sterile Water Humidifier w/5psi Adapt. Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex 350 ml Sterile Water Humidifier w/5psi Adapt. Terminated |
CAF | None listed |
| Aug 29, 2018 | SANRAI INTERNATIONAL LLC Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical p Terminated |
CAF | K091272 |
| Mar 13, 2017 | Valeant Pharmacueticals International Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a p Terminated |
CAF | K871427 |
| Feb 7, 2017 | Thayer Medical Corporation Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A.
The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non Terminated |
CAF | K111570 |
| Jun 27, 2016 | Nephron Pharmaceuticals Corp. Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60.
A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for Terminated |
CAF | K120051 |
| Jun 27, 2016 | Nephron Pharmaceuticals Corp. Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60.
A vial contains sterile, preservation-free, clear, colorless, aqueous solution as Terminated |
CAF | K120051 |
| Feb 10, 2016 | Salter Labs T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment. Terminated |
CAF | K884947 |
| Feb 10, 2016 | Pharmacaribe llc PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4
For Inhalation Only Rx
Product Usage:
The contents of these vials are used in con Terminated |
CAF | K130091 |
| Jan 21, 2016 | Valeant Pharmacueticals International Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) a Terminated |
CAF | K870051 K871427 |
| Dec 4, 2015 | Valeant Pharmaceuticals North America LLC Valeant Pharmaceuticals North America Model No. Spag-2
Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to gene Terminated |
CAF | K870051 K871427 |
| Sep 17, 2015 | Salter Labs NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or Terminated |
CAF | K961476 K962879 |
| Jun 6, 2015 | Compass Health Brands Roscoe Mini Neb Compressor User Manual for the NEB-ROS
Product Usage:
Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled. Terminated |
CAF | K031413 |
| Dec 12, 2014 | Teleflex Medical Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebuliz Terminated |
CAF | None listed |
| Oct 23, 2014 | Aerogen Ltd. The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent Terminated |
CAF | K021175 |
| Oct 23, 2014 | Aerogen Ltd. The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent Terminated |
CAF | K021175 |
| Oct 23, 2014 | Aerogen Ltd. The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent Terminated |
CAF | K021175 |
| Oct 23, 2014 | Aerogen Ltd. The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent Terminated |
CAF | K021175 |
| Jul 2, 2012 | Thayer Medical Corporation AirLife MiniSpacer MDI Dispenser Adapter. Dual-Spray MiniSpacer Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections.
The 15 mm Dual Spray MiniSpacer is a Metered Dose Inhaler (MDI) D Terminated |
CAF | K955805 |
| Aug 12, 2011 | Carefusion 211 Inc AirLife Nebulizer Heater, Catalog Code 2M8021
The AirLife Nebulizer Heater is part of the heated nebulizer system intended to provide warm bland aerosol therapy to respiratory patients. The system is Terminated |
CAF | K780456 |
| Dec 28, 2007 | Teleflex Creek Dr HUDSON RCI, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Teleflex Medical, Research Triangle Park, NC 27709. Terminated |
CAF | K772348 |
| Jan 5, 2005 | Omron Healthcare, Inc. Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model NE-U22V/NE-22VAC; Distributed by: Omron Healthcare, Inc., 300 Lakeview Parkway, Vernon Hills, IL 60061 Terminated |
CAF | K923024 |
| Nov 5, 2004 | Medical Industries America Inc Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the fo Terminated |
CAF | K032849 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.