# K983796: 6004 Nibp Monitor with Temperature

- Pathway: 510(k) (Traditional)
- Applicant: Bci Intl., Inc.
- Decided: Jan 22, 1999 after 87 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.
4 later devices descend from it; 4 cite it directly.
0 of 5 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 6004 NIBP monitor: named in the summary without a submission number
- (no number) Welch Allyn 678 SureTemp Thermometer: named in the summary without a submission number

## Most influential descendants
- K984618: Bci Mini-Torr Plus, Model 6004 (1999), 2 descendants of its own
- 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
- K993938: The Hommed Sentry, Model 1 Sentry (2000), 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 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 electronic thermometry option requires Welch Allyn thermometry probes and probe covers and provides oral or rectal temperature information for patients neonate through 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 for the NIBP and oximetry functions.

Source page: https://510kreport.com/device/K983796
Methodology: https://510kreport.com/methodology