Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103
FDA 510(k) K100077 · Solaris Medical Technology, Inc.
510(k) numberK100077
Submission
- Device name
- Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103
- Applicant
- Solaris Medical Technology, Inc.
South San Francisco, CA, US - Received
- January 12, 2010
- Decision date
- October 7, 2010
- 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 |
|---|---|---|
| K101972 | Solaris Reusable and Disposable Blood Pressure CuffsDXQ · Traditional | 07/22/2010SE |
| K092950 | Solaris Models NT1 and NT1A Handheld Pulse Oximeters with Sensor AccessoriesDQA · Special | 03/12/2010SE |
| K073249 | Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor AccessoriesDQA · Traditional | 07/25/2008SE |
| K061931 | Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103…DQA · Traditional | 01/31/2007SE |
Questions and answers
When was Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103 cleared by the FDA?
Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103 (K100077) received a 510(k) decision of Substantially Equivalent on October 7, 2010, 268 days after the submission was received.
What is the product code of K100077?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.