FDA 510(k) · OSI Medical
K012626: OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR (Osi Medical, Inc.)
Osi Medical, Inc. received FDA 510(k) K012626 for OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR, with a decision date of Nov 2, 2001 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K012626 |
|---|---|
| Pathway | 510(k) |
| Applicant | Osi Medical, Inc. |
| Device name | OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Aug 13, 2001 |
| Decision date | Nov 2, 2001 |
| 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 OSI Medical Dolphin Stand-Alone Pulse Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpOz sensor). The OSI Medical Dolphin Pulse Oximeter and Accessories are indicated for use with adult, pediatric, and neonatal patients who are well or poorly perfused in hospitals, hospital-type facilities and home environments. The OSI! Medical’s sensor(s) are intended/indicated for use only with the OSI Medical Dolphin Stand-Alone Pulse Oximeter, and consist of the following: Digital Dolphin Disposable Sensors Digital Dolphin 210 Reusable Finger Clip intended for adults / pediatrics greater than 66.14 ‘bs. (30kg). Digital Dolphin 110 Extension Cable The OSI Medical extension cable is intended/indicated for use only with the OSI Medical sensor(s) and the OS! Medical Dolphin Stand-Alone Pulse Oximeter. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of OG Tol. (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number: Ko lau Prescription Use / OR over-the-counter Use CONFIDENTIAL AND PROPRIETARY
Extracted automatically from FDA's 510(k) summary with OCR. 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.