Nitronox Scavenger Plus
FDA 510(k) K223452 · Parker Hannifin Corporation
510(k) numberK223452
Submission
- Device name
- Nitronox Scavenger Plus
- Applicant
- Parker Hannifin Corporation
Hatfield, PA, US - Received
- November 15, 2022
- Decision date
- March 5, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBN – Apparatus, Gas-Scavenging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5430
- Specialty
- Anesthesiology
Other 510(k)s with product code CBN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193646 | Dynamic Gas Scavenging System 2 (DGSS - 2)CBN · Special | Anesthetic Gas Reclamation, Inc. | 12/04/2020SE |
| K160950 | MiniscavCBN · Traditional | Sedation Systems, LLC | 05/05/2017SE |
| K142138 | Iso-Gard MaskCBN · Traditional | Teleflexmedical, Inc. | 10/30/2014SE |
| K132729 | Iso-Gard MaskCBN · Special | Teleflexmedical, Inc. | 01/09/2014SE |
| K123176 | Iso-Gard Clearair MaskCBN · Traditional | Teleflexmedical, Inc. | 02/14/2013SE |
| K110930 | Active Waste Gas ScavengerCBN · Special | G. Dundas Co.,Inc. | 06/23/2011SE |
| K092031 | Vapor-Clear, Model 100CBN · Traditional | Axon Medical, Inc. | 04/16/2010SE |
| K080039 | Passive Waste Gas Scavenger, Model 14600CBN · Traditional | G. Dundas Co.,Inc. | 04/14/2008SE |
| K072255 | Minrad Inc. Nasal Scavenging CircuitCBN · Traditional | Minrad, Inc. | 10/18/2007SE |
| K063519 | Dynamic Gas Scavenging System (DGSS)CBN · Traditional | Anesthetic Gas Reclamation, LLC | 12/01/2006SE |
More from Anesthetic Gas Reclamation, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K241465 | Midas Flowmeter; eAVSBZR · Traditional | 09/19/2024SE |
| K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50BZR · Traditional | 04/22/2021SE |
| K173530 | Indego(R)PHL · Traditional | 01/31/2018SE |
| K171334 | IndegoPHL · Traditional | 09/08/2017SE |
| K161731 | Cleveland Multiport Ventricular Catheter SetHCA · Traditional | 03/27/2017SE |
| K152416 | IndegoPHL · Traditional | 02/26/2016SE |
| K897086 | Parker Ambulatory Medication Infusion Pump 2004FRN · Traditional | 09/28/1990SE |
| K863532 | Modified Labeling to Model 2000 Ambulatory InfuserFRN · Traditional | 01/14/1987SE |
| K834461 | Infusion Pump PrimerFRN · Traditional | 01/30/1984SE |
| K833723 | Model 2000 Ambulatory Med. InfuserFRN · Traditional | 01/30/1984SE |
Questions and answers
When was Nitronox Scavenger Plus cleared by the FDA?
Nitronox Scavenger Plus (K223452) received a 510(k) decision of Substantially Equivalent on March 5, 2023, 110 days after the submission was received.
What is the product code of K223452?
The FDA product code is CBN – Apparatus, Gas-Scavenging, a Class II (moderate risk) device regulated under 21 CFR 868.5430.