Chrysalis Intelligence · Product Codes · DQA

DQA · Unclassified

94 clearances · 62 unique sponsors

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Device class
—
Regulation —
Total clearances
94
2020-01-24 → 2026-05-29
Last 12 months
13
Unique sponsors
62
Classification details
Medical specialty
—
Review panel
—
Regulation number
—
Implant
—
Life-sustain / support
—
GMP exempt
—
Third-party review
—
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Unimed Medical Supplies, Inc. 9 5 2026-04-14
Masimo Corporation 6 0 2023-12-15
Beijing Choice Electronic Technology Co., Ltd. 5 0 2024-06-21
Taiwan Aulisa Medical Devices Technologies, Inc. 3 0 2025-02-25
Avita Corporation 3 1 2026-02-27
Shenzhen Viatom Technology Co., Ltd. 2 0 2025-02-28
Shenzhen AOJ Medical Technology Co., Ltd. 2 0 2024-07-01
Shenzhen Med-Link Electronics Tech Co., Ltd. 2 0 2022-05-20
Shenzhen Imdk Medical Technology Co., Ltd. 2 1 2026-05-11
Belun Technology Company Limited 2 0 2024-10-11
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. 2 1 2026-02-17
Covidien, LLC 2 0 2022-05-06
Shenzhen Witleaf Medical Electronics Co., Ltd. 2 0 2023-02-26
Hunan Accurate Bio-Medical Technology Co., Ltd. 2 0 2025-01-02
Biobeat Technologies , Ltd. 2 0 2022-12-30
Leadtek Research, Inc. 2 0 2021-09-01
Shenzhen Narig Bio-Medical Technology Co., Ltd. 1 0 2022-01-14
Nonin Medical, Inc. 1 0 2020-06-29
Shenzhen Yimi Life Technology Co., Ltd. 1 0 2024-10-25
Shenzhen Changkun Technology Co., Ltd. 1 0 2023-05-04
Wesper, Inc. 1 0 2022-06-10
Shenzhen Bsx Technology Electronics Co., Ltd. 1 0 2020-12-14
Guangdong Genial Technology Co., Ltd. 1 0 2023-10-31
Bodimetrics, LLC 1 0 2023-08-29
Shenzhen Best Electronics Co., Ltd. 1 1 2026-01-07
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
94760 CPT — High CPT 94760 is standard for non-invasive ear or pulse oximetry
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-29 K252821 Philips Medizin Systeme Böblingen GmbH Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
2026-05-11 K252655 Shenzhen Imdk Medical Technology Co., Ltd. Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
2026-05-01 K253887 Philips Medizin Systeme Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
2026-04-14 K260931 Unimed Medical Supplies, Inc. Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
2026-02-27 K252448 Avita Corporation AViTA Pulse Oximeter (SP61)
2026-02-17 K252805 Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
2026-01-07 K253109 Shenzhen Best Electronics Co., Ltd. Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)
2025-12-19 K251751 Shenzhen Ykd Technology Co., Ltd. Spo2 Sensor CSS032D
2025-12-01 K251696 Unimed Medical Supplies, Inc. Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)
2025-12-01 K251691 Unimed Medical Supplies, Inc. Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)
2025-11-18 K251695 Unimed Medical Supplies, Inc. Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)
2025-11-18 K251693 Unimed Medical Supplies, Inc. Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)
2025-09-25 K250837 Shanghai Berry Electronic Tech Co., Ltd. Pulse Oximeter
2025-08-13 K250931 Unimed Medical Supplies, Inc. Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)
2025-05-09 K241086 Avidhrt, Inc. Avidhrt Sense SpO2
2025-02-28 K242876 Shenzhen Viatom Technology Co., Ltd. Pulse Oximeter ( PO2, PO2A, PO2B)
2025-02-25 K233963 Taiwan Aulisa Medical Devices Technologies, Inc. Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
2025-02-20 K243086 Unimed Medical Supplies, Inc. Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)
2025-02-19 K242455 Avita Corporation AViTA Pulse Oximeter (SP62B)
2025-02-06 K242580 Unimed Medical Supplies, Inc. Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)
2025-01-30 K233956 Taiwan Aulisa Medical Devices Technologies, Inc. Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
2025-01-02 K243049 Hunan Accurate Bio-Medical Technology Co., Ltd. Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)
2024-11-29 K241090 Movano Inc. Dba Movano Health Evie Med Ring
2024-11-21 K232520 Shenzhen Smallsignal Technology Co., Ltd. Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH
2024-10-25 K240092 Shenzhen Yimi Life Technology Co., Ltd. Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence