AViTA Pulse Oximeter (SP61)— 510(k) K252448
Substantially EquivalentAvita Corporation
FDA 510(k) clearance K252448 for AViTA Pulse Oximeter (SP61), Substantially Equivalent on 2026-02-27. Applicant: Avita Corporation. Device class: 2.
Summary
Avita Corporation filed the AViTA Pulse Oximeter (SP61) under product code DQA, oximeter. The record doesn't describe it beyond the name and that code name.
Class II, 21 CFR 870.2700. The Anesthesiology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
The record lists the applicant location as New Taipei City, with country code CN. FDA found it substantially equivalent 207 calendar days after receipt (August 4, 2025 to February 27, 2026).
Clearance details
- Applicant
- Avita Corporation
- 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
- Traditional
- Location
- New Taipei City, 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)
- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
More clearances from Avita Corporation
view allAdverse 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.