ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM— 510(k) K122262

Name: FDA 510(k) clearance K122262
Creator: U.S. Food and Drug Administration
Published: 2012-10-25

Substantially Equivalent

Haemonetics Corp.

FDA 510(k) clearance K122262 for ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM, Substantially Equivalent on 2012-10-25. Applicant: Haemonetics Corp.. Device class: 2.

Clearance details

Applicant: Haemonetics Corp.
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 2012-07-27
Decision date: 2012-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado Hills, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAC

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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

More clearances from Haemonetics Corp.

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K120586 — CELL SAVER ELITE2012-05-22
K101907 — HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM2010-12-03
K062801 — SMARTSUCTION SOLO DEVICE2006-10-04
K061103 — HAEMONETICS 40U RBC FILTER BAG2006-05-17
K053000 — HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)2005-11-21

Adverse events under product code CAC

product code CAC

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 →

Recalls naming K122262

K-number listed on FDA's recall record

Z-2951-2018 — Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical proceduresClass II·Terminated·Haemonetics Corporation·20180713

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122262.

Data sourced from openFDA. This site is unofficial and independent of the FDA.