Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1320360

FEI Number

3000210521

Entity Name

CURBELL MEDICAL PRODUCTS, INC.

City/State/Country

ORCHARD PARK, NY, US

Establishment Address

20 Centre Dr, ORCHARD PARK, NY 14127, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

CURBELL MEDICAL PRODUCTS, INC. (Owner Number: 9033808)

Owner / Operator Contact Address

20 CENTRE DR., --, Orchard Park, NY 14127, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Clear Choice Lead Adapter Clear Clip Clear Tab/Snap Adapter Sure-Lock Electrode Clip Clear tab/DIN Adapter Reusable Electrode Adapter ECG Adapter Clip Curbell Reuseable lead wires; OnePatient Disposable lead wires Curbell Patient Monitoring Cables Classic Sealed Click BC201 Monitor Safe Mobility Light Rego Safe Mobility App

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2008-08-08
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2018-11-12
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-04-19
ILQ	System, Communication, Powered	Physical Medicine	Class 2	890.3710	2006-12-07
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	1998-05-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CURBELL MEDICAL PRODUCTS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880323	Medtronic Vascular	MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR	1988-03-22
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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2939520	VOLCANO CORPORATION	Rancho Cordova, CA, US
3017636737	STERIS Corporation de Republica Dominicana, S.R.L.	Santo Domingo, DO
3004859241	BOSTON SCIENTIFIC CORPORATION	La Aurora Heredia, CR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1320360. Last updated year: 2026. Please use registration number 1320360 when referencing this establishment in official correspondence.