Star 90
FDA 510(k) K150512 · Skanray Technologies Pvt, Ltd.
510(k) numberK150512
Submission
- Device name
- Star 90
- Applicant
- Skanray Technologies Pvt, Ltd.
Mysore, IN - Received
- February 27, 2015
- Decision date
- June 17, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
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| K260438 | Vital Signs Monitor (CLEO2)MWI · Traditional | Infinium Medical, Inc. | 08/14/2026SE |
| K253417 | Masimo Root Monitoring SystemMWI · Traditional | Masimo Corporation | 08/12/2026SE |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)MWI · Traditional | Midmark Corporation | 06/12/2026SE |
| K253436 | c-med0 alphaMWI · Traditional | Cosinuss GmbH | 04/30/2026SE |
| K250135 | WAVE Clinical Platform (2.0.000)MWI · Traditional | Baxter Healthcare Corp/ Excel Medical | 01/16/2026SE |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)MWI · Traditional | Fysicon BV | 08/27/2025SE |
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| K241958 | WARD-CSS (v1.2.x)MWI · Traditional | Ward 24/7 Aps | 02/14/2025SE |
| K243146 | iCare APPMWI · Traditional | Ihealth Labs, Inc. | 02/03/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | Welch Allyn, Inc. | 12/20/2024SE |
More from Welch Allyn, Inc.
| 510(k) | Device | Decision |
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| K251893 | Skan C PulsarOWB · Traditional | 12/16/2025SE |
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| K212940 | Skanmobile, Skanmobile-DrIZL · Traditional | 03/04/2022SE |
| K172147 | Star 65MWI · Traditional | 05/25/2018SE |
| K111330 | Air Techniques High Frequency Intra-Oral X-RayEHD · Traditional | 05/27/2011SE |
| K103579 | Intra Skan DCEHD · Traditional | 03/18/2011SE |
Questions and answers
When was Star 90 cleared by the FDA?
Star 90 (K150512) received a 510(k) decision of Substantially Equivalent on June 17, 2015, 110 days after the submission was received.
What is the product code of K150512?
The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.