Bio-Med Corp. Disp. Non-Sterile Transdu

Q: What is the product code of K801985?

The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.

FDA 510(k) K801985 · Bio-Med Corp.

Substantially Equivalent

510(k) numberK801985

Submission

Device name: Bio-Med Corp. Disp. Non-Sterile Transdu
Applicant: Bio-Med Corp.
Mchenry, IL, US
Received: August 19, 1980
Decision date: September 9, 1980
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: DRS – Transducer, Blood-Pressure, Extravascular
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2850
Specialty: Cardiovascular

Other 510(k)s with product code DRS

510(k)	Device	Applicant	Decision
K254074	TruPressDRS · Traditional	Procerus Enterprises	09/10/2026SE
K242909	FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsDRS · Special	Edwards Lifesciences, LLC	03/21/2025SE
K221782	Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesDRS · Traditional	Merit Medical Pte. , Ltd.	03/17/2023SE
K172458	HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…DRS · Traditional	Smiths Medical Asd, Inc.	11/09/2017SE
K163172	HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…DRS · Traditional	Smiths Medical Asd, Inc.	05/24/2017SE
K161408	Compass Cast and MAPDRS · Traditional	Centurion Medical Products Corporation	11/22/2016SE
K152472	Disposable Pressure TransducerDRS · Traditional	Zhejiang Haisheng Medical Device Co., Ltd.	10/31/2016SE
K152980	Flo Trac sensor, Volume View sensorDRS · Traditional	Edwards Lifesciences, LLC	01/19/2016SE
K151040	Art-line Single channel blood pressure system, Art-line Double channel blood pressure…DRS · Traditional	Biometrix , Ltd.	09/04/2015SE
K133624	Compass CT, Compass CT PortDRS · Traditional	Mirador Biomedical	04/18/2014SE

More from Mirador Biomedical

510(k)	Device	Decision
K823286	Models DPT 1000/DPT 1000NSDRS · Traditional	12/30/1982SE
K810735	Disposable, Sterile Transducer DomesDRS · Traditional	05/08/1981SE
K802092	HF-100 DialyzerFJI · Traditional	12/18/1980SE
K802069	Disp. Transducer Domes TD200 & TD300DRS · Traditional	09/09/1980SE

Questions and answers

When was Bio-Med Corp. Disp. Non-Sterile Transdu cleared by the FDA?

Bio-Med Corp. Disp. Non-Sterile Transdu (K801985) received a 510(k) decision of Substantially Equivalent on September 9, 1980, 21 days after the submission was received.

What is the product code of K801985?

The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.