# K984618: Bci Mini-Torr Plus, Model 6004

- Pathway: 510(k) (Traditional)
- Applicant: Bci Intl., Inc.
- Decided: Mar 25, 1999 after 86 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 K953415 (1995). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970801: Bci Model 6004 Nibp Monitor  (6004), Bci Intl., Inc. (1997) Summary page 1.
- K983796: 6004 Nibp Monitor with Temperature, Bci Intl., Inc. (1999). Cleared while this submission was under review Summary page 1.
- K953415: 6200 Vital Signs Monitor, Bci Intl., Inc. (1995) Summary page 1.

## Most influential descendants
- K160667: Anybattery C2 Rechargeable Battery (2017), 0 descendants of its own
- K031742: Bci 6004 Nibp Monitor with Nellcor Pulse Oximeter (2003), 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 BCI Mini-Torr Plus monitor is a portable noninvasive blood pressure (NIBP) monitor for spot checking or monitoring of a patient’s systolic, diastolic, and mean arterial (MAP) blood pressures, and pulse rate. Optional oximeter, electronic thermometer and/or integral printer are available. The device will provide fast, reliable NIBP measurements on patients ranging form neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. The oximetry option works with all BCl oximetry probes, providing SpO2 and pulse rate on all patients from neonate to adult. The electronic thermometry option requires Welch Allyn thermometry probes and probe covers, and provides oral or rectal temperature information for neonate through adult patients. The device is intended for use in both clinical and ground EMS environments by heaith care professionals. ltis not intended for home use. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals for the NIBP and oximetry functions.

Source page: https://510kreport.com/device/K984618
Methodology: https://510kreport.com/methodology
