Biobeat Platform-2 and BB-613WP Patch

FDA 510(k) K222010 · Biobeat Technologies , Ltd.

Substantially Equivalent

510(k) numberK222010

Submission

Device name
Biobeat Platform-2 and BB-613WP Patch
Applicant
Biobeat Technologies , Ltd.
Petah Tikvah, IL
Received
July 7, 2022
Decision date
December 30, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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

510(k)DeviceApplicantDecision
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
K241066BB-613-BPMDXN · Traditional 01/14/2025SE
K212153Biobeat Platform, BB-613WP PatchDQA · Traditional 03/25/2022SE
K190792BB-613WPDQA · Traditional 08/22/2019SE

Questions and answers

When was Biobeat Platform-2 and BB-613WP Patch cleared by the FDA?

Biobeat Platform-2 and BB-613WP Patch (K222010) received a 510(k) decision of Substantially Equivalent on December 30, 2022, 176 days after the submission was received.

What is the product code of K222010?

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