FDA 510(k) · Oxypulse
K100815: OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 (Oxypulse)
Oxypulse received FDA 510(k) K100815 for OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316, with a decision date of Jun 16, 2010 (substantially equivalent).
Prescription or OTC: Prescription (Rx) parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K100815 |
|---|---|
| Pathway | 510(k) |
| Applicant | Oxypulse |
| Device name | OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Mar 23, 2010 |
| Decision date | Jun 16, 2010 |
| 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
Statement Report No.: US20100201 Indication for use 510(k) Number (if nco, KJ 00815 Device Name: OxiBlire Fhwertip Pulse Oximeter and OxiPro Fingertip Pulse Oximeter Indications for Use: The OxiBlue Fingertip PI,~K xinnetcr is indicated for continuous or spot-checking in measuring and displaying function,, '<O> on saturation (Sp02) and pulse rate of patients in hospitals and home care. It is intended for adil and pediatric patients on finger between 0.3-1.0 inch (0.8 -2.5 cm) thick. The Oxialue can trailsmi invi either a USB cable or wireless Bluetooth technology. The OxiPro Fingertip Pul~pr) .Xuneter is indicated for continuous or spot-checking in measuring and displaying functional arte: I! oxyp,,en saturation (SpO 2 ) and pulse rate of patients in hospitals and home care. It is intended for adrht and( )ediatric patients on finger between 0.3-1.0 inch (0.8 -2.5 cm) thick. The OxiPro can tranm~7 >2 't i LIC cale and does not include Bluetooth technology. Prescription Use X Over-The-Cou8nter Use _____ (Part 21CFR 801Subpcii D) AND/OR (21 CIFR 801. Subpart C) (PLEASE DO NOT \-7- 3$! TH,'I-IS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) C- -rrence of CDRH, Office of Device Evaluation (ODE) .Division Sign-Oft) 'ivision of Anesthesiology, General Hospital
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
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
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.