MaxO2ME
FDA 510(k) K153659 · Maxtec, LLC
510(k) numberK153659
Submission
- Device name
- MaxO2ME
- Applicant
- Maxtec, LLC
Salt Lake City, UT, US - Received
- December 21, 2015
- Decision date
- June 10, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCL – Analyzer, Gas, Oxygen, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1720
- Specialty
- Anesthesiology
Other 510(k)s with product code CCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)CCL · Traditional | Salter Labs | 07/30/2026SE |
| K251245 | OxyMinder Pro (10310)CCL · Traditional | Bio-Med Device, Inc. | 08/11/2025SE |
| K250002 | Smart Check O2 (MA0236)CCL · Traditional | Life Spark Medical, LLC | 04/24/2025SE |
| K221734 | Maxtec MaxO2 ME+pCCL · Traditional | Maxtec, LLC | 04/01/2023SE |
| K213933 | Percent Oxygen SensorsCCL · Traditional | Careox, LLC | 08/19/2022SE |
| K213948 | OxyMinderCCL · Traditional | Bio-Med Devices, Inc. | 03/17/2022SE |
| K173807 | Accu O2 Oxygen AnalyzerCCL · Abbreviated | Precision Medical, Inc. | 05/02/2018SE |
| K123195 | Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesCCL · Traditional | GE Healthcare Finland Oy | 02/28/2013SE |
| K122290 | Envitec Mysign O Oxygen Measuring DeviceCCL · Traditional | Envitec-Wismar GmbH | 01/23/2013SE |
| K112402 | ULTRAMAXO2 Oxygen AnalyerCCL · Abbreviated | Maxtec, LLC | 12/14/2011SE |
More from Maxtec, LLC
| 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 |
| K161718 | MaxBlend 2, MaxBlend LiteBZR · Traditional | 10/27/2016SE |
| 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 MaxO2ME cleared by the FDA?
MaxO2ME (K153659) received a 510(k) decision of Substantially Equivalent on June 10, 2016, 172 days after the submission was received.
What is the product code of K153659?
The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.