Submission Details
| 510(k) Number | K253142 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 25, 2025 |
| Decision Date | January 09, 2026 |
| Days to Decision | 106 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)
Jan 2026
Decision
106d
Days
Class 2
Risk
About This 510(k) Submission
K253142 is an FDA 510(k) clearance for the Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D), a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Ningbo Ranor Medical Technology Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on January 9, 2026, 106 days after receiving the submission on September 25, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.
Device Classification
| Product Code | DXN — System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1130 |
Manufacturer
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