Home / 510(k) Clearances / K251102

510(k) K251102

Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) by Cemho Medical Technology (Guangdong) Co., Ltd. — Product Code DXN

K251102 is an FDA 510(k) premarket notification submitted by Cemho Medical Technology (Guangdong) Co., Ltd. for the device "Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603)". The FDA issued a decision of Substantially Equivalent on July 16, 2025. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2025
Date Received
April 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

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  • K253124 — Upper arm electronic blood pressure monitor (XB-01) (June 3, 2026)
  • K253570 — Blood Pressure Monitor (W06LT) (May 20, 2026)
  • K254048 — Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19 (May 14, 2026)
  • K253152 — BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) (May 6, 2026)
  • K260260 — Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521 (April 28, 2026)
  • K252501 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, D (April 28, 2026)
  • K253982 — Korotkoff sound blood pressure monitor (April 21, 2026)

FDA data resources