Pulse Oximeter
FDA 510(k) K191403 · Nonin Medical, Inc.
510(k) numberK191403
Submission
- Device name
- Pulse Oximeter
- Applicant
- Nonin Medical, Inc.
Plymouth, MN, US - Received
- May 24, 2019
- Decision date
- December 20, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQA – Oximeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
Other 510(k)s with product code DQA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…DQA · Traditional | Philips Medizin Systeme Böblingen GmbH | 05/29/2026SE |
| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO…DQA · Traditional | Shenzhen Imdk Medical Technology Co., Ltd. | 05/11/2026SE |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…DQA · Traditional | Philips Medizin Systeme | 05/01/2026SE |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQA · Special | Unimed Medical Supplies, Inc. | 04/14/2026SE |
| K252448 | AViTA Pulse Oximeter (SP61)DQA · Traditional | Avita Corporation | 02/27/2026SE |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)DQA · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 02/17/2026SE |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)DQA · Traditional | Shenzhen Best Electronics Co., Ltd. | 01/07/2026SE |
| K251751 | Spo2 Sensor CSS032DDQA · Traditional | Shenzhen Ykd Technology Co., Ltd. | 12/19/2025SE |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
More from Unimed Medical Supplies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K211498 | Nonin OTC Pulse Oximeter Model 3250OLK · Traditional | 11/13/2024SE |
| K192900 | H500 Multi-Sensing Oximetry SystemDQA · Traditional | 06/29/2020SE |
| K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…MUD · Traditional | 05/02/2019SE |
| K172625 | Reusable, Finger Clip Nonin Medical CO-Met Oximetry SensorDQA · Traditional | 05/11/2018SE |
| K160231 | Model X-100C CO-Met Oximetry SystemDQA · Traditional | 12/23/2016SE |
| K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series:…DQA · Traditional | 08/05/2016SE |
| K151305 | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…MUD · Traditional | 08/27/2015SE |
| K140785 | Pulse OximeterDQA · Traditional | 07/07/2014SE |
| K132402 | Sensmart Model X-100 Univeral Oximetry SystemDQA · Traditional | 02/21/2014SE |
| K131021 | Pulse OximeterDQA · Traditional | 09/11/2013SE |
Questions and answers
When was Pulse Oximeter cleared by the FDA?
Pulse Oximeter (K191403) received a 510(k) decision of Substantially Equivalent on December 20, 2019, 210 days after the submission was received.
What is the product code of K191403?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.