510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043582Substantially Equivalent

Ocean Chest Drain

Atrium Medical Corporation, Hudson NH / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K043582 is the FDA 510(k) clearance record for OCEAN CHEST DRAIN, a class II device, cleared for Atrium Medical Corp. on under FDA product code KDQ (Bottle, Collection, Vacuum). FDA records list 69 510(k) clearances for Atrium Medical Corp., from to . As of , FDA records show 22 recalls naming K043582.

Clearance record

Decision date
Received
(24 days to decision)
Product code
KDQ Bottle, Collection, Vacuum
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Atrium Medical Corp. 5 Wentworth Dr., Hudson NH
510(k) summary
Statement
Third party review
No

Clearances, product code KDQ

Trailing 12 months

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

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