Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)— 510(k) K260931
Substantially EquivalentUnimed Medical Supplies, Inc.
FDA 510(k) clearance K260931 for Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R), Substantially Equivalent on 2026-04-14. Applicant: Unimed Medical Supplies, Inc.. Device class: 2.
Summary
Unimed Medical Supplies' Reusable Finger Clip SpO2 Sensors come in two models, U403-49R and U103-49R, filed under product code DQA (Oximeter). The record doesn't say how the two differ.
Class II, 21 CFR 870.2700. The Anesthesiology review panel handled it as a Special 510(k), though the record lists Cardiovascular as the classification panel.
Unimed Medical Supplies filed from Shenzhen, China. The record shows 25 calendar days from receipt to decision (March 20 to April 14, 2026).
Clearance details
- Applicant
- Unimed Medical Supplies, Inc.
- Product code
- Product code DQA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Shenzhen, CN
Recent devices under product code DQA
view all- K260490 — Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14)
- K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
- K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
- K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
- K252448 — AViTA Pulse Oximeter (SP61)
More clearances from Unimed Medical Supplies, Inc.
view all- K253162 — Temperature probes (5 models)
- K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N)
- K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (4 models)
- K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48) +1 more
- K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (5 models)
Adverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.