510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063690Substantially Equivalent

Colin Press Mate, Model Bp S510

Omron Healthcare Co., Ltd., Bonita Springs FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K063690 is the FDA 510(k) clearance record for COLIN PRESS MATE, MODEL BP S510, a class II device, cleared for Omron Healthcare, Inc. on under FDA product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)). FDA records list 68 510(k) clearances for Omron Healthcare, Inc., from to . As of , FDA records show no recalls naming K063690.

Clearance record

Decision date
Received
(148 days to decision)
Product code
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Omron Healthcare, Inc. 3460 Pt.e Creek Ct. #102, Bonita Springs FL
510(k) summary
Statement
Third party review
No

Clearances, product code MHX

Trailing 12 months
15 clearances under product code MHX in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MHX, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20261
March 20260
April 20263
May 20262
June 20261
July 20261
August 20263
September 20261
October 20260