Biosurge Model Oasys-Ii

FDA 510(k) K875023 · Biosurge, Inc.

Substantially Equivalent

510(k) numberK875023

Submission

Device name
Biosurge Model Oasys-Ii
Applicant
Biosurge, Inc.
Rochester, NY, US
Received
December 4, 1987
Decision date
February 12, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CAC – Apparatus, Autotransfusion
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5830
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code CAC

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K241236XTRA Collection sets; XTRA Sequestration set XCAC · Special Sorin Group Italia S.R.L.08/16/2024SE
K240426Aventus Clot Management SystemCAC · Traditional Inquis Medical05/14/2024SE
K240584XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special Sorin Group Italia S.R.L.04/29/2024SE
K231782FlowSaver Blood Return System (80-101)CAC · Special Inari Medical, Inc.07/14/2023SE
K221483FlowSaver Blood Return SystemCAC · Traditional Inari Medical, Inc.02/17/2023SE
K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional Haemonetics Corporation11/15/2022SE
K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional Atrium Medical Corporation09/03/2021SE
K210862Hemafuse SystemCAC · Traditional Sisu Global Health07/29/2021SE
K210176FlowSaver Blood FilterCAC · Traditional Inari Medical07/22/2021SE
K210089CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special Fresenius Kabi AG02/11/2021SE

More from Fresenius Kabi AG

510(k)DeviceDecision
K884620Asd Single Lumen NeedleFMI · Traditional 11/21/1988SE
K875016Biosurge Model ILVC-1DWS · Traditional 02/29/1988SE
K874602Asd-Bio Anti-Stick DeviceFMI · Traditional 02/19/1988SE
K871258Biosurge Model OasysCAC · Traditional 05/21/1987SE

Questions and answers

When was Biosurge Model Oasys-Ii cleared by the FDA?

Biosurge Model Oasys-Ii (K875023) received a 510(k) decision of Substantially Equivalent on February 12, 1988, 70 days after the submission was received.

What is the product code of K875023?

The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.