# K052544: Pulse Oximeter Adapter Cables

- Pathway: 510(k) (Abbreviated)
- Applicant: American I.V. Products, Inc.
- Decided: Sep 29, 2006 after 379 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). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001020: 8100 Vital Signs Monitor, Criticare Systems, Inc. (2000) Summary page 1.
- K934959: Model 118 Fetal/Maternal Monitor, Ge Medical Systems Information Technologies (1994) Summary page 1.
- K993531: Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX, Datascope Corp. (2000) Summary page 1.
- K033304: Modification to Dash 3000/4000 Patient Monitor, Ge Medical Systems Information Technologies (2003) Summary page 1.
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999)
- K993637: N-395 Pulse Oximeter, with Extended Device Claims, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K973147: NPB-295 Pulse Oximeter, Nellcor Puritan Bennett, Inc. (1997) Summary page 1.
- K971946: NPB-190 Pulse Oximeter (NPB-190), Nellcor Puritan Bennett, Inc. (1997) Summary page 1.
- K901209: Model 90489 Pulse Oximeter Module, Spacelabs, Inc. (1990) Summary page 1.
- K972502: Spacelabs Medical Integrated Multiparameter Module 90496, Spacelabs Medical, Inc. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K097006: Datascope Model 0012-00-0516-02. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K012467: Solar 8000M System, General Electric Medical Systems Information Techn (2002). Our reading of the summary gave K012467, FDA’s number for Solar 8000M System (General Electric Medical Systems Information Techn). Its FDA name has none of the distinctive words the summary uses for the device it names, “GE Medical Systems Models E9004GE and 2006644-001”. Kept off the family tree. Summary page 1.
- K014159: Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient Monitor, Philips Medical Systems, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K993383: HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A, M3046A, M3015A, Rel.B, Hewlett-Packard GmbH (2000). Our reading of the summary gave K993383, FDA’s number for HP Viridia Multi-Measurement Server/Compact Portable… (Hewlett-Packard GmbH). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips Model M1941A”. Kept off the family tree. Summary page 1.
- K021453: Heartstream XL Defibrillator/Monitor, Model #M4735A, Philips Medical Systems (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
These devices are intended to be used as replacement accessories to Original Equipment Manufacturer monitors used in the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. These systems are used to monitor patients who are either well or poorly perfused, in hospitals, hospital type facilities, intra-hospital transport and home environments.

Source page: https://510kreport.com/device/K052544
Methodology: https://510kreport.com/methodology