510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K031000Substantially Equivalent

Labsystem III Ep Laboratory W/windows Platform & Windows Ep Software Version 1.0

C.R. Bard Inc, Lowell MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031000 is the FDA 510(k) clearance record for LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0, a class II device, cleared for C.R. Bard, Inc. on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K031000.

Clearance record

Decision date
Received
(64 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
C.R. Bard, Inc. 55 Technology Dr., Lowell MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQK

Trailing 12 months
27 clearances under product code DQK in the twelve months to November 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20262
November 20260