510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944257Substantially Equivalent

Lionheart 3 Multi-Parameter Simulator

Bio-Tek Instruments, Inc., Winooski VT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944257 is the FDA 510(k) clearance record for LIONHEART 3 MULTI-PARAMETER SIMULATOR, a class II device, cleared for Bio-Tek Instruments, Inc. on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list 37 510(k) clearances for Bio-Tek Instruments, Inc., from to . As of , FDA records show no recalls naming K944257.

Clearance record

Decision date
Received
(21 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
Bio-Tek Instruments, Inc. Highland Park, Winooski VT
510(k) summary
Statement
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