Pulse-Ox
FDA 510(k) K863857 · Life Design Systems, Inc.
510(k) numberK863857
Submission
- Device name
- Pulse-Ox
- Applicant
- Life Design Systems, Inc.
Carrollton, TX, US - Received
- October 2, 1986
- Decision date
- October 7, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K913714 | Modification Manual Pulmon Resuscitor/Pulmanex(Tm)BTM · Traditional | 12/01/1992SE |
| K885313 | Humidi-Flex TMBYD · Traditional | 10/11/1989SE |
| K893030 | Child Size - Filter Flex (TM)CAH · Traditional | 09/18/1989SE |
| K892862 | Flex-Cup PercussorBYI · Traditional | 05/25/1989SE |
| K892221 | Pulmonary Resuscitator, ModificationBTM · Traditional | 05/18/1989SE |
| K890011 | Oxygen Connector and Oxygen Delivery TubingBZO · Traditional | 03/20/1989SE |
| K890108 | Modified Cushion-Flex(Tm)BSJ · Traditional | 01/24/1989SE |
| K884387 | Cushion Flex(Tm)BSJ · Traditional | 11/17/1988SE |
| K884068 | Pulmanex TM (Neo-Natal Size)BTM · Traditional | 11/16/1988SE |
| K873179 | Heater Wire Breathing CircuitBZE · Traditional | 03/31/1988SE |
Questions and answers
When was Pulse-Ox cleared by the FDA?
Pulse-Ox (K863857) received a 510(k) decision of Substantially Equivalent on October 7, 1987, 370 days after the submission was received.
What is the product code of K863857?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.