FDA 510(k) · Belun
K211407: Belun Ring BLR-100X (Belun Technology Company Limited)
Belun Technology Company Limited received FDA 510(k) K211407 for Belun Ring BLR-100X, with a decision date of Oct 21, 2021 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K211407 |
|---|---|
| Pathway | 510(k) |
| Applicant | Belun Technology Company Limited |
| Device name | Belun Ring BLR-100X |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | May 6, 2021 |
| Decision date | Oct 21, 2021 |
| 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
Belun Ring BLR-100X is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for continuous data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment for up to ten hours, during no motion and motion conditions, and for patients who are well or poorly perfused. It is not intended for single-use and out-of-hospital transport use and does not have alarms. 2/10 Belun Technology Company Limited BLR-100X Ring Type Pulse Oximeter 510(k) Notification
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.
Later records that cite K211407
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 Ring PPG. These are heuristics, not FDA fields.