MaxBlend 2, MaxBlend Lite
FDA 510(k) K161718 · Maxtec, LLC
510(k) numberK161718
Submission
- Device name
- MaxBlend 2, MaxBlend Lite
- Applicant
- Maxtec, LLC
Salt Lake City, UT, US - Received
- June 22, 2016
- Decision date
- October 27, 2016
- 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 |
| 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 |
|---|---|---|
| K231895 | Maxtec MaxBlend2+pBZR · Traditional | 12/04/2023SE |
| K221734 | Maxtec MaxO2 ME+pCCL · Traditional | 04/01/2023SE |
| K182362 | MaxCap Ped and MaxCap NeoCCK · Traditional | 05/23/2019SE |
| K153659 | MaxO2MECCL · Traditional | 06/10/2016SE |
| K133540 | FlocapCCK · Traditional | 03/28/2014SE |
| K113232 | Maxmixing BlockBZR · Traditional | 03/01/2012SE |
| K112402 | ULTRAMAXO2 Oxygen AnalyerCCL · Abbreviated | 12/14/2011SE |
| K063488 | MAXO2 CuCCL · Traditional | 02/22/2007SE |
| K040484 | MAXO2+, Model a and AeCCL · Traditional | 06/09/2004SE |
Questions and answers
When was MaxBlend 2, MaxBlend Lite cleared by the FDA?
MaxBlend 2, MaxBlend Lite (K161718) received a 510(k) decision of Substantially Equivalent on October 27, 2016, 127 days after the submission was received.
What is the product code of K161718?
The FDA product code is BZR – Mixer, Breathing Gases, Anesthesia Inhalation, a Class II (moderate risk) device regulated under 21 CFR 868.5330.