510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011310Substantially Equivalent

Nien Made Non-Invasive Blood Pressure Monitor, Models Hp-Bpm0001; Hp-Bpm0002; Hp-Bpm0003; Hp-Bpm0003-1

Nien Made Electrnics Corp., Concord MA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K011310 is the FDA 510(k) clearance record for NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1, a class II device, cleared for Nien Made Electrnics Corp. on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list 2 510(k) clearances for Nien Made Electrnics Corp., from to . As of , FDA records show no recalls naming K011310.

Clearance record

Decision date
Received
(81 days to decision)
Product code
DXN System, Measurement, Blood-Pressure, Non-Invasive
Regulation
21 CFR 870.1130
Device class
Class II
Review panel
Cardiovascular
Applicant
Nien Made Electrnics Corp. 100 Main St., Concord MA
510(k) summary
Summary
Third party review
No

Clearances, product code DXN

Trailing 12 months
30 clearances under product code DXN in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DXN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20264
March 20262
April 20265
May 20263
June 20264
July 20262
August 20264
September 20262
October 20261