510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K883031Substantially Equivalent

Q-Cath Rm

Quinton, Inc., Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883031 is the FDA 510(k) clearance record for Q-CATH RM, a class II device, cleared for Quinton, Inc. on under FDA product code DXJ (Display, Cathode-Ray Tube, Medical). FDA records list 164 510(k) clearances for Quinton, Inc., from to . As of , FDA records show no recalls naming K883031.

Clearance record

Decision date
Received
(63 days to decision)
Product code
DXJ Display, Cathode-Ray Tube, Medical
Regulation
21 CFR 870.2450
Device class
Class II
Review panel
Cardiovascular
Applicant
Quinton, Inc. 2121 Terry Ave., Seattle WA
Third party review
No

Clearances, product code DXJ

Trailing 12 months

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

FDA records show no clearances under product code DXJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXJ, 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