FDA 510(k) · Masimo
K050252: AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS (Masimo Corporation)
Masimo Corporation received FDA 510(k) K050252 for AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS, with a decision date of May 11, 2005 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K050252 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Feb 3, 2005 |
| Decision date | May 11, 2005 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
510(k) Number (if known): Device Name: AC-I Adapter Cable, 8 pin and 12 pin Philips Indications For Use: The AC-I Adapter Cable, 8 pin and 12 pin Philips is indicated for the continuous noninvasive monitoring of functik oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO 2 sensor) for use with adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments. Prescription Use _X_ AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (Per 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign- .ff) Division of Anestfoesiology, General HoupiW, Infection Control, Dental Devices 510(k) Number: k o~ O %~ST (OO
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.