Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DQA — Predicate Candidate Screening
726 FDA 510(k) clearances under this product code; the 50 most recent screened below.
125 daysmedian FDA review time
326 days90th percentile
726clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adul | Philips Medizin Systeme Böblingen GmbH | 2026-05-29 | 267 | 0 |
| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-05-11 | 262 | 0 |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Senso | Philips Medizin Systeme | 2026-05-01 | 148 | 0 |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103- | Unimed Medical Supplies, Inc. | 2026-04-14 | 25 | 0 |
| K252448 | AViTA Pulse Oximeter (SP61) | Avita Corporation | 2026-02-27 | 207 | 0 |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-17 | 167 | 0 |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) | Shenzhen Best Electronics Co., Ltd. | 2026-01-07 | 105 | 0 |
| K251751 | Spo2 Sensor CSS032D | Shenzhen Ykd Technology Co., Ltd. | 2025-12-19 | 193 | 0 |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed | Unimed Medical Supplies, Inc. | 2025-12-01 | 182 | 0 |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U4 | Unimed Medical Supplies, Inc. | 2025-12-01 | 182 | 0 |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed | Unimed Medical Supplies, Inc. | 2025-11-18 | 169 | 0 |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed | Unimed Medical Supplies, Inc. | 2025-11-18 | 169 | 0 |
| K250837 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | 2025-09-25 | 189 | 0 |
| K250931 | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-11 | Unimed Medical Supplies, Inc. | 2025-08-13 | 138 | 0 |
| K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. | 2025-05-09 | 385 | 0 |
| K242876 | Pulse Oximeter ( PO2, PO2A, PO2B) | Shenzhen Viatom Technology Co., Ltd. | 2025-02-28 | 158 | 0 |
| K233963 | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2025-02-25 | 438 | 0 |
| K243086 | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U | Unimed Medical Supplies, Inc. | 2025-02-20 | 143 | 0 |
| K242455 | AViTA Pulse Oximeter (SP62B) | Avita Corporation | 2025-02-19 | 184 | 0 |
| K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed | Unimed Medical Supplies, Inc. | 2025-02-06 | 160 | 0 |
| K233956 | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2025-01-30 | 412 | 0 |
| K243049 | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximet | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2025-01-02 | 97 | 0 |
| K241090 | Evie Med Ring | Movano Inc. Dba Movano Health | 2024-11-29 | 221 | 0 |
| K232520 | Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine | Shenzhen Smallsignal Technology Co., Ltd. | 2024-11-21 | 461 | 0 |
| K240092 | Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM | Shenzhen Yimi Life Technology Co., Ltd. | 2024-10-25 | 287 | 0 |
| K234110 | Belun Ring BLR-200 (BLR-200) | Belun Technology Company Limited | 2024-10-11 | 289 | 0 |
| K240808 | Pulse Oximeter (WS20A) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2024-10-03 | 192 | 0 |
| K233827 | OxiWear | Oxiwear, Inc. | 2024-08-28 | 271 | 0 |
| K231979 | Mecun SpO2 sensor | Shenzhen Mecun Medical Supply Co., Ltd. | 2024-08-16 | 408 | 0 |
| K232989 | Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Ox | Shenzhen AOJ Medical Technology Co., Ltd. | 2024-07-01 | 283 | 0 |
| K232975 | Pulse Oximeter (MD300C228) | Beijing Choice Electronic Technology Co., Ltd. | 2024-06-21 | 274 | 0 |
| K240305 | ANNE Limb | Sibel Health, Inc. | 2024-05-28 | 116 | 0 |
| K223399 | AViTA Pulse Oximeter | Avita Corporation | 2024-05-20 | 558 | 0 |
| K232495 | Sempulse Halo Vital Signs Monitor | Sempulse Corporation | 2024-05-16 | 273 | 0 |
| K231288 | Vyvo | Vyvo Technology Corp.(Vt) | 2024-03-04 | 305 | 0 |
| K230277 | Pulse Oximeter(Model OHT60,OXH78) | Cofoe Medical Technology Co., Ltd. | 2024-01-04 | 337 | 0 |
| K231531 | Pediarity™ | Hinlab, Inc. | 2023-12-21 | 209 | 0 |
| K223721 | Masimo Stork | Masimo Corporation | 2023-12-15 | 368 | 0 |
| K230587 | Wrist Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2023-11-30 | 273 | 0 |
| K231243 | Finger Clip Pulse Oximeter | Guangdong Genial Technology Co., Ltd. | 2023-10-31 | 183 | 0 |
| K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue | Masimo Corporation | 2023-09-07 | 29 | 0 |
| K221361 | circul™ pro Ring | Bodimetrics, LLC | 2023-08-29 | 475 | 0 |
| K230172 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2023-08-12 | 204 | 0 |
| K211143 | Pulse Oximeter | Shenzhen Brav Electronic Technologies Co., Ltd. | 2023-07-17 | 822 | 0 |
| K222597 | BabySat 3 | Owlet Babycare, Inc. | 2023-06-16 | 291 | 0 |
| K221798 | Finger Pulse Oximeter, Model: X1906P | Shenzhen Changkun Technology Co., Ltd. | 2023-05-04 | 317 | 0 |
| K213676 | Masimo Rad-G with Temperature | Masimo Corporation | 2023-04-16 | 510 | 2 |
| K220101 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2023-03-08 | 420 | 0 |
| K213431 | Handheld Pulse Oximeter | Shenzhen Witleaf Medical Electronics Co., Ltd. | 2023-02-26 | 493 | 0 |
| K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies , Ltd. | 2022-12-30 | 176 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda