510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K871363Substantially Equivalent

Model 420 System Measurement, Blood Pressure

Quinton, Inc., Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871363 is the FDA 510(k) clearance record for MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE, a class II device, cleared for Quinton, Inc. on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list 164 510(k) clearances for Quinton, Inc., from to . As of , FDA records show no recalls naming K871363.

Clearance record

Decision date
Received
(59 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
Quinton, Inc. 2121 Terry Ave., Seattle WA
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