Masimo Lncs/M-Lncs Oximetry Sensors
FDA 510(k) K101896 · Masimo Corporation
510(k) numberK101896
Submission
- Device name
- Masimo Lncs/M-Lncs Oximetry Sensors
- Applicant
- Masimo Corporation
Irvine, CA, US - Received
- July 7, 2010
- Decision date
- October 21, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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.
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| K253417 | Masimo Root Monitoring SystemMWI · Traditional | 08/12/2026SE |
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| K254209 | Radius VSM and AccessoriesMHX · Traditional | 06/04/2026SE |
| K243324 | Masimo O3 Regional OximeterMUD · Traditional | 07/17/2025SE |
| K250757 | Radius VSM and AccessoriesMHX · Traditional | 05/29/2025SE |
| K243305 | Masimo W1DPS · Traditional | 04/03/2025SE |
| K240229 | Masimo W1DPS · Traditional | 08/08/2024SE |
| K234021 | Masimo StorkQYU · Traditional | 05/03/2024SE |
| K214115 | MightySat -OTCOLK · Traditional | 01/31/2024SE |
| K223721 | Masimo StorkDQA · Traditional | 12/15/2023SE |
Questions and answers
When was Masimo Lncs/M-Lncs Oximetry Sensors cleared by the FDA?
Masimo Lncs/M-Lncs Oximetry Sensors (K101896) received a 510(k) decision of Substantially Equivalent on October 21, 2010, 106 days after the submission was received.
What is the product code of K101896?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.