510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852232Substantially Equivalent

Pressure Display Box #60000/Tubing Set #61000

Dlp, Inc., Grand Rapids MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852232 is the FDA 510(k) clearance record for PRESSURE DISPLAY BOX #60000/TUBING SET #61000, a class II device, cleared for Dlp, Inc. on under FDA product code DXS (Gauge, Pressure, Coronary, Cardiopulmonary Bypass). FDA records list 39 510(k) clearances for Dlp, Inc., from to . As of , FDA records show 4 recalls naming K852232.

Clearance record

Decision date
Received
(79 days to decision)
Product code
DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Regulation
21 CFR 870.4310
Device class
Class II
Review panel
Cardiovascular
Applicant
Dlp, Inc. P.O.Box 409, Grand Rapids MI
Third party review
No

Clearances, product code DXS

Trailing 12 months

FDA records hold no clearances under product code DXS in the trailing twelve months.

FDA records show no clearances under product code DXS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260