510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K897125Substantially Equivalent

Atrium 2000, Chest Drain

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

K897125 is the FDA 510(k) clearance record for ATRIUM 2000, 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 no recalls naming K897125.

Clearance record

Decision date
Received
(94 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. 17 Clinton Dr., Hollis NH
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KDQ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260