# K033349: AC-1 SP02 Adaptor Cable, Model AC-1

- Pathway: 510(k) (Special)
- Applicant: Masimo Corp.
- Decided: Jan 28, 2004 after 100 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962603 (1997). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031330: Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables, Masimo Corp. (2003) Summary page 1.
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K863784: Nellcor N-200 (Pulse Oximeter), Nellcor, Inc. (1986) Summary page 1.

## Most influential descendants
- K083448: Cable, Transducer, Model 2400GN (2009), 0 descendants of its own
- K050252: AC-1 Adapter Cable, 8 Pin and 12 Pin Philips (2005), 0 descendants of its own

## Indications for use
The AC-I Adapter Cable with Masimo sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO₂ sensor) for use with adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K033349
Methodology: https://510kreport.com/methodology