FDA 510(k) · Shenzhen Jumper Medical Equipment
K140582: FINGERTIP PULSE OXIMETER (Shenzhen Jumper Medical Equipment Co., Ltd.)
Shenzhen Jumper Medical Equipment Co., Ltd. received FDA 510(k) K140582 for FINGERTIP PULSE OXIMETER, with a decision date of Aug 28, 2014 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K140582 |
|---|---|
| Pathway | 510(k) |
| Applicant | Shenzhen Jumper Medical Equipment Co., Ltd. |
| Device name | FINGERTIP PULSE OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Mar 6, 2014 |
| Decision date | Aug 28, 2014 |
| 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
510(k) Number (if known): K140582 Device Name: Fingertip Pulse Oximeter Model: JPD-500A Indications for Use: The JPD-500A Fingertip Pulse Oximeter is non-invasive device intended for spot- checking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate. The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc). Prescription Use ___Ĝ____ Over-The-Counter Use _______ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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.
- K082641 FINGERTIP PULSE OXIMETER, MODELS CMS-50… (Contec Medical System)
Later records that cite K140582
- K180685 AS-3XX Series Fingertip Pulse Oximeter (Xiamen Acurio Instruments, Nov 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 Finger PPG. These are heuristics, not FDA fields.