510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822388Substantially Equivalent

Life Trace 14

Life Science Instrumentation, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822388 is the FDA 510(k) clearance record for LIFE TRACE 14, a class II device, cleared for Life Science Instrumentation, Inc. on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list 20 510(k) clearances for Life Science Instrumentation, Inc., from to . As of , FDA records show no recalls naming K822388.

Clearance record

Decision date
Received
(15 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
Life Science Instrumentation, Inc. 4221 Richmond Rd., NW, Walker MI
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