FDA 510(k) · Leadtek Research
K210032: Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) (Leadtek Research, Inc.)
Leadtek Research, Inc. received FDA 510(k) K210032 for Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless), with a decision date of Sep 1, 2021 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K210032 |
|---|---|
| Pathway | 510(k) |
| Applicant | Leadtek Research, Inc. |
| Device name | Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jan 5, 2021 |
| Decision date | Sep 1, 2021 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Fingertip Pulse Oximeter (Wireless) are Fingertip Pulse Oximeter are intended intended for measuring functional for measuring functional oxygen oxygen saturation of arterial saturation of arterial hemoglobin hemoglobin (SpO2) and pulse rate for (SpO2) and pulse rate for both adults both adults and adolescent as and adolescent as non-invasive spot Intended Use non-invasive spot checking in home checking in home and professional and professional caring environment. It caring environment. It is designed for is designed for fingers between 0.8cm fingers between 0.8cm and 2.3cm (0.3 and 2.3cm (0.3 inches to 0.9 inches) inches to 0.9 inches) and for patients and for patients during no-motion during no-motion condition. condition. Population adults and adolescent patients adults and adolescent patients Application Finger Finger site Performance normal condition normal condition Stand-alone stand-alone stand-alone or module Single use or multiple use multiple use not Use home and professional caring home and professional caring environment environment environment
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.
- K193350 Leadtek Fingertip Pulse Oximeter (Leadtek Research)
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.