510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K890114Substantially Equivalent

Imex Rhythm Tek

Racom, Inc., Rg7 4lp, Berkshire, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890114 is the FDA 510(k) clearance record for IMEX RHYTHM TEK, a class II device, cleared for Racom, Inc. on under FDA product code DSH (Recorder, Magnetic Tape, Medical). FDA records list one 510(k) clearance for Racom, Inc. As of , FDA records show no recalls naming K890114.

Clearance record

Decision date
Received
(197 days to decision)
Product code
DSH Recorder, Magnetic Tape, Medical
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Racom, Inc. Unit 1 Theale Tech. Centre, Rg7 4lp, Berkshire, GB
Third party review
No

Clearances, product code DSH

Trailing 12 months
3 clearances under product code DSH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260