# K970801: Bci Model 6004 Nibp Monitor  (6004)

- Pathway: 510(k) (Traditional)
- Applicant: Bci Intl., Inc.
- Decided: Nov 12, 1997 after 253 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BCI 6100 Vital Signs Monitor: named in the summary without a submission number

## Most influential descendants
- K984618: Bci Mini-Torr Plus, Model 6004 (1999), 2 descendants of its own
- K982279: Vital Signs Monitor; Advisor Model # Bci 9200 (1998), 2 descendants of its own
- K030407: Advisor, Model 9200 (2003), 1 descendant of its own
- K160667: Anybattery C2 Rechargeable Battery (2017), 0 descendants of its own
- K061931: Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103, S200A-090101 and 300101 (2007), 0 descendants of its own

## 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 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 SpO, and/or integral printer. The device will provide fast, reliable measurements on patients ranging from children (pediatric) to adults when using the appropriate BCI blood pressure cuff. The oximetry option works with all BCI oximetry probes, providing SpO, and pulse rate on all patients from neonate to adult. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

Source page: https://510kreport.com/device/K970801
Methodology: https://510kreport.com/methodology