Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
FDA 510(k) K202480 · Parker Hannifin
510(k) numberK202480
Submission
- Device name
- Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
- Applicant
- Parker Hannifin
Hatfield, PA, US - Received
- August 28, 2020
- Decision date
- April 22, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- BZR – Mixer, Breathing Gases, Anesthesia Inhalation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5330
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BZR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243917 | F&P Optiflow Air/Oxygen Flow SourceBZR · Traditional | Fisher & Paykel Healthcare, Ltd. | 07/14/2025SE |
| K241465 | Midas Flowmeter; eAVSBZR · Traditional | Parker Hannifin Corporation | 09/19/2024SE |
| K231895 | Maxtec MaxBlend2+pBZR · Traditional | Maxtec, LLC | 12/04/2023SE |
| K230987 | FlowStar Analog Mixer FlowmeterBZR · Traditional | Baldus Sedation GmbH & Co. KG | 09/14/2023SE |
| K222794 | FlowStar Touch Digital Mixer FlowmeterBZR · Traditional | Baldus Sedation GmbH & Co. KG | 07/28/2023SE |
| K221494 | Quality Mix Blender, OxymixerBZR · Traditional | Dehas Medical Systems GmbH | 01/23/2023SE |
| K173205 | Equinox AdvantageBZR · Traditional | O-Two Medical Technologies, Inc. | 08/29/2018SE |
| K161718 | MaxBlend 2, MaxBlend LiteBZR · Traditional | Maxtec, LLC | 10/27/2016SE |
| K142291 | GMX Series Medical Air/Oxygen BlenderBZR · Traditional | Gentec (Shanghai) Corporation | 05/19/2015SE |
| K113687 | Equinox RelieveBZR · Traditional | O-Two Medical Technologies, Inc. | 04/30/2012SE |
More from O-Two Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241465 | Midas Flowmeter; eAVSBZR · Traditional | 09/19/2024SE |
| K223452 | Nitronox Scavenger PlusCBN · Traditional | 03/05/2023SE |
| 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 Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 cleared by the FDA?
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 (K202480) received a 510(k) decision of Substantially Equivalent on April 22, 2021, 237 days after the submission was received.
What is the product code of K202480?
The FDA product code is BZR – Mixer, Breathing Gases, Anesthesia Inhalation, a Class II (moderate risk) device regulated under 21 CFR 868.5330.