FDA 510(k) · Jiangsu Konsung Bio-Medical Science & Technology
K152089: Wrist Pulse Oximeter (Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.)
Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. received FDA 510(k) K152089 for Wrist Pulse Oximeter, with a decision date of Aug 17, 2016 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K152089 |
|---|---|
| Pathway | 510(k) |
| Applicant | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. |
| Device name | Wrist Pulse Oximeter |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jul 27, 2015 |
| Decision date | Aug 17, 2016 |
| 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 Wrist Pulse Oximeter is intended for spot checking in measuring and displaying oxygen saturation of functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospitals, hospital facilities and home healthcare 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.
- K122046 WRIST PULSE OXIMETER (Beijing Choice Electronic Technology)
Later records that cite K152089
- K180174 Belun Ring (Belun, May 29, 2018, DQA)
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 Wrist PPG. These are heuristics, not FDA fields.