Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain— 510(k) K201305

Clearance details

Applicant

Atrium Medical Corporation

Product code

Code CAC

Device class

Class 2

Regulation

21 CFR 868.5830

Advisory panel

Anesthesiology

Date received

2020-05-15

Decision date

2021-09-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Merrimack, NH, US

• K241236 — XTRA Collection sets; XTRA Sequestration set X2024-08-16
• K240426 — Aventus Clot Management System2024-05-14
• K240584 — XTRA Autotransfusion System (with XTRA Bowl sets)2024-04-29
• K231782 — FlowSaver Blood Return System (80-101)2023-07-14
• K221483 — FlowSaver Blood Return System2023-02-17

• K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft2024-03-28
• K151386 — C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic2015-10-22
• K151437 — ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug2015-08-27
• K130142 — FLIXENE IFG VASCULAR GRAFT2013-03-15
• K110110 — ATRIUM CENTRILFX MESH2011-02-15

Death

11

Malfunction

477

Total

488

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0710-2024 — Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery UnitClass I·Ongoing·Maquet Cardiovascular, LLC·20231213
• Z-0316-2024 — Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ; (6)2012-320 DRAIN, OCEAN PEDI W/S; (7)2050-000 DRAIN, OCEAN BRU W/AC,SClass II·Ongoing·Atrium Medical Corporation·20230918
• Z-0317-2024 — Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;Class II·Ongoing·Atrium Medical Corporation·20230918
• Z-0318-2024 — Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRUClass II·Ongoing·Atrium Medical Corporation·20230918

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201305.