510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K150908Substantially Equivalent

XM-01 Electronic Automatic Blood Pressure Monitor

Sky Innovation Technology ( Shanghai) Limited, Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150908 is the FDA 510(k) clearance record for XM-01 Electronic Automatic Blood Pressure Monitor, a class II device, cleared for Sky Innovation Technology ( Shanghai) Limited on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list one 510(k) clearance for Sky Innovation Technology ( Shanghai) Limited. As of , FDA records show no recalls naming K150908.

Clearance record

Decision date
Received
(257 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
Sky Innovation Technology ( Shanghai) Limited 9th Floor Hechuan Bldg.,, Shanghai, CN
510(k) summary
Summary PDF
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