510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890876Substantially Equivalent

Bp-8800 Blood Pressure Monitor

Colin Medical Instruments Corp., South Plainfield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890876 is the FDA 510(k) clearance record for BP-8800 BLOOD PRESSURE MONITOR, a class II device, cleared for Colin Medical Instruments Corp. on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list 15 510(k) clearances for Colin Medical Instruments Corp., from to . As of , FDA records show no recalls naming K890876.

Clearance record

Decision date
Received
(121 days to decision)
Product code
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Colin Medical Instruments Corp. 107g Corporate Blvd., South Plainfield NJ
Third party review
No

Clearances, product code DRT

Trailing 12 months
4 clearances under product code DRT in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260