Star 65
FDA 510(k) K172147 · Skanray Technologies Pvt, Ltd.
510(k) numberK172147
Submission
- Device name
- Star 65
- Applicant
- Skanray Technologies Pvt, Ltd.
Mysore, IN - Received
- July 17, 2017
- Decision date
- May 25, 2018
- 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 |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | Empatica S.r.l. | 06/06/2025SE |
| 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 |
|---|---|---|
| K251893 | Skan C PulsarOWB · Traditional | 12/16/2025SE |
| K231761 | PodSKAN HF Diagnostic X-ray SystemKPR · Traditional | 10/27/2023SE |
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| K212940 | Skanmobile, Skanmobile-DrIZL · Traditional | 03/04/2022SE |
| K150512 | Star 90MWI · Traditional | 06/17/2015SE |
| 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 65 cleared by the FDA?
Star 65 (K172147) received a 510(k) decision of Substantially Equivalent on May 25, 2018, 312 days after the submission was received.
What is the product code of K172147?
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.