Precision Blender
FDA 510(k) K053232 · Precision Medical, Inc.
510(k) numberK053232
Submission
- Device name
- Precision Blender
- Applicant
- Precision Medical, Inc.
Northampton, PA, US - Received
- November 18, 2005
- Decision date
- January 10, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50BZR · Traditional | Parker Hannifin | 04/22/2021SE |
| 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 |
More from Gentec (Shanghai) Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K173807 | Accu O2 Oxygen AnalyzerCCL · Abbreviated | 05/02/2018SE |
| K140179 | Easy Go VacBTA · Special | 04/25/2014SE |
| K103563 | Precision Portable Oxygen Concentration Model 4150CAW · Traditional | 07/01/2011SE |
| K103324 | Precision Liquid Oxygen SystemBYJ · Traditional | 04/21/2011SE |
| K090781 | HELIO2 BlenderBZR · Traditional | 08/13/2009SE |
| K072348 | Precision Oxygen ConcentratorCAW · Abbreviated | 10/27/2008SE |
| K063096 | Precision Oxygen MonitorCCL · Abbreviated | 02/27/2007SE |
| K051691 | Minimate CompressorBTI · Traditional | 12/09/2005SE |
| K041122 | Precision Liquid Oxygen SystemBYJ · Traditional | 10/04/2004SE |
| K032018 | Easy Pulse II Oxygen ConserverNFB · Traditional | 08/25/2003SE |
Questions and answers
When was Precision Blender cleared by the FDA?
Precision Blender (K053232) received a 510(k) decision of Substantially Equivalent on January 10, 2006, 53 days after the submission was received.
What is the product code of K053232?
The FDA product code is BZR – Mixer, Breathing Gases, Anesthesia Inhalation, a Class II (moderate risk) device regulated under 21 CFR 868.5330.