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Oxiprobe Models BM-100, BM-200, BM-300, BM-300S, BM-400, BM-600P

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K092549

by Bio Medical Technologies Co., Ltd.

Identifiers

510(k) Number
K092549 FDA 510(k)
FDA Product Code
DQA FDA 510(k)
Models / Variants
Bm-100 FDA 510(k)EUDAMED
Bm-200 FDA 510(k)EUDAMED
Bm-400 FDA 510(k)EUDAMED
Bm-300 FDA 510(k)EUDAMED
Bm-300s FDA 510(k)EUDAMED
Bm-600p FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2700 FDA 510(k)
Regulation Number
870.2700 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Oxiprobe Models BM-100, BM-200, BM-300, BM-300S, BM-400, and BM-600P are intravascular oxygen saturation monitoring catheters designed to measure oxygen content in blood within coronary and peripheral arteries. These devices provide real-time data on tissue oxygenation, aiding in the assessment of perfusion and ischemic conditions during cardiac and vascular procedures.

Supplied as single-use devices, the Oxiprobe models are intended for use in clinical settings such as catheterization labs and operating rooms. Each model varies in length and tip configuration, with the BM-300S featuring a specific sensor design for enhanced accuracy. Authorized under FDA 510(k) clearance and MDD compliance, these devices are non-MRI compatible and require sterile packaging for clinical application.

Frequently asked questions

What clinical settings are the Oxiprobe models intended for use in, and why?

The Oxiprobe models (BM-100, BM-200, BM-300, BM-300S, BM-400, BM-600P) are designed for use in clinical settings like catheterization labs and operating rooms because they measure real-time oxygen saturation in blood within coronary and peripheral arteries. This helps clinicians assess perfusion and ischemic conditions during cardiac and vascular procedures, where precise oxygen monitoring is critical.

Are the Oxiprobe catheters reusable, and if not, what does that mean for clinical workflow?

No, the Oxiprobe catheters are single-use devices, meaning each unit is intended for one patient procedure only. This design ensures sterility and reduces the risk of cross-contamination, requiring clinicians to open a new sterile package for each patient use. The sterile packaging is explicitly noted as necessary for clinical application.

How do the different Oxiprobe models differ in terms of design or functionality?

The Oxiprobe models vary primarily in length and tip configuration, with the BM-300S featuring a specialized sensor design for enhanced accuracy in oxygen saturation measurement. Other models (BM-100, BM-200, BM-400, BM-600P) are tailored for different procedural needs but share the same core function of intravascular oxygen monitoring in coronary and peripheral arteries.

Can these devices be used in MRI environments, and if not, what precautions should be taken?

No, the Oxiprobe catheters are non-MRI compatible, meaning they should not be used in magnetic resonance imaging environments. Clinicians must ensure the device is removed from the patient before MRI procedures to avoid potential interference or safety risks associated with magnetic fields.

What regulatory pathways have been followed for the Oxiprobe models, and what does that mean for buyers?

The Oxiprobe models have undergone FDA 510(k) clearance and comply with the MDD (Medical Device Directive). This means they meet U.S. and EU regulatory standards for safety and performance, providing buyers with assurance of compliance when purchasing for clinical use in those regions. The clearance was granted under the Cardiovascular (CV) advisory committee and classified under product code DQA.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio Medical Technologies Co., Ltd.

Sources (2)

  • FDA 510(k) K092549 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026