Panels › Cardiovascular › Product code DQA · Class 2

Oximeter

Regulation 870.2700

13510(k)s in 12 months (727 all time)

9recalls in 12 months (128 all time)

101recalls that name a 510(k)

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Top companies in DQA

Company	510(k)s	Recalls
Masimo Corp.	77	14
Nonin Medical, Inc.	42	3
Oridion Medical 1987 , Ltd.	1	32
Philips Healthcare Inc.	0	25
Nellcor Puritan Bennett, Inc.	19	4
Beijing Choice Electronic Technololgy Co., Ltd.	21	0
Philips Medical Systems	8	5
Covidien	10	2
Dolphin Medical, Inc.	12	0
Bci Intl., Inc.	11	0

Date	Firm and product	Code	Linked 510(k)
Feb 12, 2026	SUREPULSE MEDICAL LTD Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor Open, Classified	DQA	K201887
Feb 12, 2026	SUREPULSE MEDICAL LTD Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor Open, Classified	DQA	K201887
Feb 12, 2026	SUREPULSE MEDICAL LTD Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor Open, Classified	DQA	K201887
Feb 12, 2026	SUREPULSE MEDICAL LTD Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor Open, Classified	DQA	K201887
Feb 12, 2026	SUREPULSE MEDICAL LTD Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor Open, Classified	DQA	K201887
Jan 22, 2026	Edan Diagnostics Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monito Open, Classified	DQA	K131818
Jan 22, 2026	Edan Diagnostics Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital p Open, Classified	DQA	K101539
Jan 22, 2026	Edan Diagnostics Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including Open, Classified	DQA	K180380
Jan 22, 2026	Edan Diagnostics Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor Open, Classified	DQA	K131818
Jul 21, 2025	Covidien Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN Open, Classified	DQA	K120773 K142865
Oct 31, 2024	Accriva Diagnostics, Inc. AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter. Completed	DQA	K922075
Oct 30, 2024	Nihon Kohden America Inc Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each Open, Classified	DQA	None listed
Oct 30, 2024	Nihon Kohden America Inc Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box Open, Classified	DQA	None listed
Sep 10, 2024	Zoe Medical Incorporated Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331 Open, Classified	DQA	K150620
Sep 10, 2024	Zoe Medical Incorporated Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330 Open, Classified	DQA	K093802
Apr 12, 2024	Masimo Corporation Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, Open, Classified	DQA	K213676
Apr 12, 2024	Masimo Corporation Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, Open, Classified	DQA	K201770
Apr 12, 2024	Masimo Corporation Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, Open, Classified	DQA	K201770
Apr 12, 2024	Masimo Corporation Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, Open, Classified	DQA	K213676
Jun 21, 2023	Masimo Corporation Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 Open, Classified	DQA	K051212
Jun 21, 2023	Masimo Corporation Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 Open, Classified	DQA	K051212
Jun 21, 2023	Masimo Corporation Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 Open, Classified	DQA	K033296
Jun 21, 2023	Masimo Corporation Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 Open, Classified	DQA	K180046
May 8, 2019	Xhale Assurance, Inc. Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of function Terminated	DQA	K143216 K171423
Jul 31, 2018	Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 (INTL) M REFURBISHED, CS78654 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 (INTL) N REFURBISHED, CS78652 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 N CYVITAL, CS08799 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 N W/PRINTER CYVITAL, CS08798 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 M W/PRINTER CYVITAL, CS08796 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 (INTL) M W/PRINTER, CS08660 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 M NICU (CPM), CS08654RN Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 M ADULT ICU (CPM), CS08654RA Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 (INTL) M, CS08654 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. CAPNOSTREAM 20 (INTL) N, Part Number CS08652 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659 Terminated	DQA	K082268
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657 Terminated	DQA	K082268
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 (US)M REFURBISHED, Part Number CS78653 Terminated	DQA	K082268
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 (US) N REFURBISHED, Part Number CS78651 Terminated	DQA	None listed
Jul 31, 2018	Oridion Medical 1987 Ltd. Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751 Terminated	DQA	K082268

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