510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K897126Substantially Equivalent

Atrium 2050 Chest Drain Blood Recovery System

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

K897126 is the FDA 510(k) clearance record for ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM, a class II device, cleared for Atrium Medical Corp. on under FDA product code CAC (Apparatus, Autotransfusion). FDA records list 69 510(k) clearances for Atrium Medical Corp., from to . As of , FDA records show no recalls naming K897126.

Clearance record

Decision date
Received
(77 days to decision)
Product code
CAC Apparatus, Autotransfusion
Regulation
21 CFR 868.5830
Device class
Class II
Review panel
Anesthesiology
Applicant
Atrium Medical Corp. 17 Clinton Dr., Hollis NH
Third party review
No

Clearances, product code CAC

Trailing 12 months

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

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