510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K212493Substantially Equivalent

KODEX – EPD™ System 1.5.0

Philips Medical Systems Nederland, B.V. (Pmsn), Best Noord-Brabant, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212493 is the FDA 510(k) clearance record for KODEX – EPD™ System 1.5.0, a class II device, cleared for Philips Medical Systems Nederland, B.V. (Pmsn) on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list one 510(k) clearance for Philips Medical Systems Nederland, B.V. (Pmsn). As of , FDA records show no recalls naming K212493.

Clearance record

Decision date
Received
(441 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
Philips Medical Systems Nederland, B.V. (Pmsn) Veenpluis 4-6, Best Noord-Brabant, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQK

Trailing 12 months
26 clearances under product code DQK in the twelve months to October 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
November 20250
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20261