Lawrence L4000 Reflectance Pulse Oximeter

FDA 510(k) K874492 · Lawrence Medical Systems, Inc.

Substantially Equivalent

510(k) numberK874492

Submission

Device name
Lawrence L4000 Reflectance Pulse Oximeter
Applicant
Lawrence Medical Systems, Inc.
Cammarillo, CA, US
Received
November 2, 1987
Decision date
March 22, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DQA – Oximeter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2700
Specialty
Cardiovascular

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K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…DQA · Traditional Philips Medizin Systeme Böblingen GmbH05/29/2026SE
K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO…DQA · Traditional Shenzhen Imdk Medical Technology Co., Ltd.05/11/2026SE
K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…DQA · Traditional Philips Medizin Systeme05/01/2026SE
K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQA · Special Unimed Medical Supplies, Inc.04/14/2026SE
K252448AViTA Pulse Oximeter (SP61)DQA · Traditional Avita Corporation02/27/2026SE
K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)DQA · Traditional Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.02/17/2026SE
K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)DQA · Traditional Shenzhen Best Electronics Co., Ltd.01/07/2026SE
K251751Spo2 Sensor CSS032DDQA · Traditional Shenzhen Ykd Technology Co., Ltd.12/19/2025SE
K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional Unimed Medical Supplies, Inc.12/01/2025SE
K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional Unimed Medical Supplies, Inc.12/01/2025SE

More from Unimed Medical Supplies, Inc.

510(k)DeviceDecision
K874885Lawrence L3000 Cardiac Output MonitorDPW · Traditional 02/05/1988SE
K862548Temperature Sensing Esophageal TransducerBZT · Traditional 10/22/1986SE
K851426Accucom Cardiac Output MonitorDXK · Traditional 07/12/1985SE

Questions and answers

When was Lawrence L4000 Reflectance Pulse Oximeter cleared by the FDA?

Lawrence L4000 Reflectance Pulse Oximeter (K874492) received a 510(k) decision of Substantially Equivalent on March 22, 1988, 141 days after the submission was received.

What is the product code of K874492?

The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.