# K990338: Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor System

- Pathway: 510(k) (Traditional)
- Applicant: Physio-Control Corp.
- Decided: Sep 1, 1999 after 210 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914838 (1992). 3 ancestors in all.
12 later devices descend from it; 6 cite it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982135: Oscillomate Ems Nibp Monitor Model 9001, Cas Medical Systems, Inc. (1998) Summary page 1.
- K914838: Propaq 102,104,106,102EL,104EL,&106EL, Protocol Systems, Inc. (1992) Summary page 1.
- K981114: Microcap, Oridion Medical, Ltd. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K964239: Combination Oximeter/Carbon Dioxide Gas Analyzer, Spegas Industries, Ltd. (1997). Our OCR of the scanned summary read K964239, FDA’s number for Combination Oximeter/Carbon Dioxide Gas Analyzer (Spegas Industries, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “NPB-75”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K040775: Lifepak 12 (2004), 10 descendants of its own
- K041459: Lifepak 12 Defibrillator/Monitor (2004), 9 descendants of its own
- K063510: Lifepak 12 Defibrillator/Monitor (2007), 7 descendants of its own
- K082937: Lifepak 15 Monitor/Defibrillator (2009), 5 descendants of its own
- K103567: Lifepak 15 Monitor/Defibrillator (2011), 4 descendants of its own

## Recalls of this device
- Jan 27, 2003 · Not classified · Z-0542-03: Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit.

## Indications for use
The LIFEPAK®12 NIBP monitor non-invasively measures blood pressure of the adult and pediatric patients by professionally trained health care providers. It is not designed for continuous, unsupervised monitoring. The use of the LIFEPAK®12 EtCO2 monitor is indicated whenever professionally trained health care providers determine that a patient requires the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate.

Source page: https://510kreport.com/device/K990338
Methodology: https://510kreport.com/methodology