OxyMinder
FDA 510(k) clearance K213948 · decided 2022-03-17
Clearance details
- K-number
- K213948
- Device name
- OxyMinder
- Applicant
- Bio-Med Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-17
- Decision date
- 2022-03-17
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- CCL
- Device class
- 2
- Regulation number
- 868.1720
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Guilford, CT, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) (K261389) | Salter Labs | 2026-07-30 |
| OxyMinder Pro (10310) (K251245) | Bio-Med Device, Inc. | 2025-08-11 |
| Smart Check O2 (MA0236) (K250002) | Life Spark Medical, LLC | 2025-04-24 |
| Maxtec MaxO2 ME+p (K221734) | Maxtec, LLC | 2023-04-01 |
| Percent Oxygen Sensors (K213933) | Careox, LLC | 2022-08-19 |
| Accu O2 Oxygen Analyzer (K173807) | Precision Medical, Inc. | 2018-05-02 |
| MaxO2ME (K153659) | Maxtec, LLC | 2016-06-10 |
| CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES (K123195) | GE Healthcare Finland Oy | 2013-02-28 |
| ENVITEC MYSIGN O OXYGEN MEASURING DEVICE (K122290) | Envitec-Wismar GmbH | 2013-01-23 |
| ULTRAMAXO2 OXYGEN ANALYER (K112402) | Maxtec, LLC | 2011-12-14 |
| ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 (K082655) | Envitec-Wismar GmbH | 2008-11-25 |
| DIGIFLO CONCENTRATOR ANALYZER (K072469) | Digiflo, Inc. | 2008-01-03 |
Recalls involving this device
No recalls on record reference this clearance.