OXICOM-2100

FDA 510(k) K921519 · Waters Instruments, Inc.

Substantially Equivalent

510(k) numberK921519

Submission

Device name
OXICOM-2100
Applicant
Waters Instruments, Inc.
Rochester, MN, US
Received
March 31, 1992
Decision date
October 23, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code DQA

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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

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K971571RM3 Renal Preservation System--Control UnitKDN · Traditional 07/29/1997SE
K911207OxicomplusDQA · Traditional 08/26/1991SE
K863210VELCOM-100DPW · Traditional 11/26/1986SE
K862161OSC-80 OximeterDQA · Traditional 08/18/1986SE
K852909MVP - 6000BZC · Traditional 11/14/1985SE
K834408TX-2 Thermal Dilution Cardiac OutputDXG · Traditional 08/23/1984SE
K841876Polyurethane Thermal Dilution CathetDYG · Traditional 07/13/1984SE
K813585Waters Ileostomy ValveKNT · Traditional 04/09/1982SE

Questions and answers

When was OXICOM-2100 cleared by the FDA?

OXICOM-2100 (K921519) received a 510(k) decision of Substantially Equivalent on October 23, 1992, 206 days after the submission was received.

What is the product code of K921519?

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