SARN CENTRIFUGAL PUMP— 510(k) K112229

Clearance details

Applicant

Terumo Cardiovascular Systems

Product code

Code KFM

Device class

Class 2

Regulation

21 CFR 870.4360

Advisory panel

Cardiovascular

Date received

2011-08-03

Decision date

2011-12-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ann Arbor, MI, US

• K251762 — Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)2025-08-04
• K250326 — Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)2025-06-24
• K233091 — Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT) +1 more2023-10-26
• K232132 — LifeSPARC System2023-08-03
• K220842 — Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors2023-05-19

• K090698 — CAPIOX BUBBLE TRAP WITH X-COATING2009-06-08

Death

109

Injury

241

Malfunction

1,779

Total

2,129

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-1235-2017 — The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.Class II·Terminated·Terumo Cardiovascular Systems Corporation·20150527
• Z-2028-2014 — Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.Class II·Terminated·Terumo Cardiovascular Systems Corporation·20140414
• Z-2029-2014 — Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.Class II·Terminated·Terumo Cardiovascular Systems Corporation·20140414
• Z-2030-2014 — Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230, 73728, 71537, 73605-01, 74482-01, 74857-01, 74916, 73928-02, 70123-02, 71853-02, 72997-03, 74766, 71537, 73728, 72269, 74466, 71317-02 72991-02, 74951, 74336, 74121-01, 72941-01, 73315-03, 74559, 74277, 71382-01, 73108-02, 74178-03, 71598-02, 73108-02, 74618-01, 70334-03, 74802-01, 74916, 71932-02, 70951-03, 73957-01, 74857-01, 70957-02, 73449-01, 73124, 71546-02, 72892-01, 74431, 72370, 73913-01, 73957-01, 75028, 71820-01, 74201, 74402, 73891-01, 73865, 73972, 71175-01, 73208-03, 72669-02, 70533-09, 72275-01, 74369, 74321-01, 73175, B73235, 74459, 73931, 74262-01, 71002-01, 74879-01, 71801-01, 72384, 74365, 74366, 74348-01, 72072-02, 74048, 70932-03, 73407, 74879-01, 73820-01, 74161-01, 72991-02, 73288-01, 70016, 70466-08, 70188-04, 72238-02, 72817-01, 71103-02, 71717-01, 70957-02, 70196-02, 73872-02, 71896-02, 73191-01, 70977-05, 73438, 73201-01, 74671, 70367-07, 73276-02, 74482-01, 73551-02, 71537, 74348-01, 73211-01, 74430, 72026-03, 74502, 74873, 73652-01, 74163-02, 71733-02, 70075-06, 72846, 73820-01, 75063, 74155-01, 74454-01, 73428-01, 73442-01, 70664-01, 70012-05, 70099-03, 70159-05, 70917, 72965-02, 73645-01, 74417, 73346, 74433, 74737, 73055-02, 70227-04, 70880-05, 71934-02, 72073-01, 72149-01, 74120-01, 72370, 73662-03, 74251, 73872-02, 70658-09, 74550, 74124, 74096-01, 74203, 70174-09, 71485-01, 71905-01, 73124, 73874, 74467-01, 8327TXC-08, 8365TXC-01, 8390TXC, 74433, and 74737. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures.Class II·Terminated·Terumo Cardiovascular Systems Corporation·20140414

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112229.