OxyMinder
FDA 510(k) K213948 · Bio-Med Devices, Inc.
510(k) numberK213948
Submission
- Device name
- OxyMinder
- Applicant
- Bio-Med Devices, Inc.
Guilford, CT, US - Received
- December 17, 2021
- Decision date
- March 17, 2022
- 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 |
| K173807 | Accu O2 Oxygen AnalyzerCCL · Abbreviated | Precision Medical, Inc. | 05/02/2018SE |
| K153659 | MaxO2MECCL · Traditional | Maxtec, LLC | 06/10/2016SE |
| 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
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|---|---|---|
| K173973 | TV-100CBK · Traditional | 07/20/2018SE |
| K942938 | CROSSVENT-4 VentilatorCBK · Traditional | 09/19/1995ST |
| K896381 | MVP-10 MRI Infant VentilatorCBK · Traditional | 02/12/1990SE |
| K896380 | IC-2A MRI Adult/Pediatric VentilatorCBK · Traditional | 02/12/1990SE |
| K873614 | CBG Cuff ManometerBSK · Traditional | 01/22/1988SE |
| K871337 | M-2 Oxygen/Temperature MonitorCCL · Traditional | 06/05/1987SE |
| K871336 | M-1 Pressure MonitorCAP · Traditional | 06/05/1987SE |
| K871139 | M-10 Ventilation MonitorCAP · Traditional | 04/21/1987SE |
| K830230 | Programmable VentilatorCBK · Traditional | 02/09/1983SE |
| K823861 | ET-3 Emergency Transport VentilatorCBK · Traditional | 02/07/1983SE |
Questions and answers
When was OxyMinder cleared by the FDA?
OxyMinder (K213948) received a 510(k) decision of Substantially Equivalent on March 17, 2022, 90 days after the submission was received.
What is the product code of K213948?
The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.