Solaris Reusable and Disposable Blood Pressure Cuffs
FDA 510(k) K101972 · Solaris Medical Technology, Inc.
510(k) numberK101972
Submission
- Device name
- Solaris Reusable and Disposable Blood Pressure Cuffs
- Applicant
- Solaris Medical Technology, Inc.
South San Francisco, CA, US - Received
- July 13, 2010
- Decision date
- July 22, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DXQ – Blood Pressure Cuff
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1120
- Specialty
- Cardiovascular
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Other 510(k)s with product code DXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254287 | Medline Reusable Blood Pressure CuffDXQ · Traditional | Medline Industries, LP | 06/22/2026SE |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffDXQ · Traditional | Nihon Kohden Corporation | 05/06/2026SE |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122…DXQ · Traditional | Shenzhen Best Electronics Co., Ltd. | 02/13/2026SE |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N)DXQ · Special | Unimed Medical Supplies, Inc. | 01/09/2026SE |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | Baxter Healthcare Corporation | 12/16/2025SE |
| K250765 | AViTA Arm Type Blood Pressure Monitor CuffDXQ · Traditional | Avita Corporation | 09/03/2025SE |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff…DXQ · Traditional | Unimed Medical Supplies, Inc. | 07/15/2025SE |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuffDXQ · Traditional | Shenzhen Medke Technology Co., Ltd. | 10/31/2024SE |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid SphygmomanometerDXQ · Traditional | Wenzhou Longwan Medical Device Factory | 03/20/2024SE |
| K233276 | Reusable Blood Pressure CuffDXQ · Traditional | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 12/21/2023SE |
More from Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K100077 | Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103DQA · Traditional | 10/07/2010SE |
| 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 Solaris Reusable and Disposable Blood Pressure Cuffs cleared by the FDA?
Solaris Reusable and Disposable Blood Pressure Cuffs (K101972) received a 510(k) decision of Substantially Equivalent on July 22, 2010, 9 days after the submission was received.
What is the product code of K101972?
The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.