Home / 510(k) Clearances / K232053

510(k) K232053

SimpleSense-BP, SimpleSense-BP Software Application by Nanowear, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2023
Date Received
July 11, 2023
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

Other clearances by Nanowear, Inc.

  • K212160 — SimpleSENSE Platform (September 22, 2021)
  • K201669 — SimpleSENSE (November 6, 2020)
  • K161431 — SimplECG (November 30, 2016)

Other clearances for product code DXN

  • K252779 — YUWELL® Electronic Blood Pressure Monitor (YE630CR) (March 5, 2026)
  • K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR) (February 23, 2026)
  • K252685 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, (February 13, 2026)
  • K251581 — Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (February 13, 2026)
  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
  • K251307 — Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) (January 12, 2026)
  • K253142 — Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) (January 9, 2026)
  • K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (December 19, 2025)
  • K251331 — Blood Pressure Monitor (B73, BE23T) (October 27, 2025)
  • K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) (October 9, 2025)