# K031742: Bci 6004 Nibp Monitor with Nellcor Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Bci, Inc.
- Decided: Aug 18, 2003 after 75 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- 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: 6 generations back to K962603 (1997). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984618: Bci Mini-Torr Plus, Model 6004, Bci Intl., Inc. (1999) Summary page 1.
- K983796: 6004 Nibp Monitor with Temperature, Bci Intl., Inc. (1999) Summary page 1.
- K970801: Bci Model 6004 Nibp Monitor  (6004), Bci Intl., Inc. (1997) Summary page 1.
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2002) Summary page 1.
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002)

## Recalls of this device
- Apr 2, 2008 · Not classified · Z-1649-2008: Due to a component that may be installed backwards, the device may turn off or may immediately reset.

## Indications for use
The 6004 NIBP monitor is a low cost portable NIBP monitor for spot checking or monitoring of a patient’s systolic, diastolic and mean arterial (MAP) blood pressures, and pulse rate, with optional Sp02, optional oralhectal temperature, and/or integral printer. The device will provide NIBP measurements on patients ranging from neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. An LED indicator illuminates when the monitor is configured for NIBP neonate mode. The BCI oximetry options work with all BCI oximetry sensors when providing SpOl and pulse rate on all patients from neonate to adult in both NIBP adult and neonate mode. The Nellcor oximetry option provides SpOl and pulse rate data on adult patients using the Nellcor DS lOOA sensor. The electronic thermometry option is intended for intermittent “spot checks” of oral or rectal temperature for patients neonate through adult and requires WelchAl lyn thermometry probes and probe covers. The temperature option works for all patients in NIBP adult or neonate mode. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use.

Source page: https://510kreport.com/device/K031742
Methodology: https://510kreport.com/methodology