FDA 510(k) · Xiamen Acurio Instruments
K180685: AS-3XX Series Fingertip Pulse Oximeter (Xiamen Acurio Instruments Co., Ltd.)
Xiamen Acurio Instruments Co., Ltd. received FDA 510(k) K180685 for AS-3XX Series Fingertip Pulse Oximeter, with a decision date of Nov 29, 2018 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K180685 |
|---|---|
| Pathway | 510(k) |
| Applicant | Xiamen Acurio Instruments Co., Ltd. |
| Device name | AS-3XX Series Fingertip Pulse Oximeter |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Mar 15, 2018 |
| Decision date | Nov 29, 2018 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The AS-3XX Series Fingertip Pulse Oximeter (with models AS-301, AS-302, AS-301-L, AS-302-L, AS-303, AS-304, AS-304-L and AS-311) is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult in hospitals, hospital-type facilities, and home environments.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K140582 FINGERTIP PULSE OXIMETER (Shenzhen Jumper Medical Equipment)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DQA is "Oximeter", class 2, 21 CFR 870.2700.
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.