510(k) · Cleared
Recalled · 2008Bci Mini-Torr Plus, Model 6004
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bci Intl., Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 25, 1999 as substantially equivalent to K970801 (Bci Intl., Inc., 1997) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 25, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- DXN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K953415 (1995). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK953415 6200 Vital Signs MonitorBci Intl., Inc. · 1995
- This deviceK984618 Bci Mini-Torr Plus, Model 6004Bci Intl., Inc. · 1999
- Descendant · cites it directly · 0 of its ownK160667 Anybattery C2 Rechargeable BatteryAnybattery, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK031742 Bci 6004 Nibp Monitor with Nellcor Pulse OximeterBci, Inc. · 2003 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953415 | 6200 Vital Signs Monitor | Bci Intl., Inc. | 1995 | — |
| 0 (this device) | K984618 | Bci Mini-Torr Plus, Model 6004 | Bci Intl., Inc. | 1999 | — |
| +1 | K160667 | Anybattery C2 Rechargeable Battery | Anybattery, Inc. | 2017 | — |
| +1 | K031742 | Bci 6004 Nibp Monitor with Nellcor Pulse Oximeter | Bci, Inc. | 2003 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970801 | Bci Model 6004 Nibp Monitor (6004)Summary page 1…i-Torr Plus (model 6004) with new neonate NIBP mode Common/Classification Name: Noninvasive blood pressure measurement system Predicate Devices: BCI 6004 NIBP Monitor (K970801) BCI 6004 Monitor with Temperature Option, 510(k) pending (K983796) BCI 6200 Vital Signs Monitor (K953415) New Device Descripti… | 1997 |
| * | K983796 | 6004 Nibp Monitor with Temperature Cleared while this submission was under review Summary page 1…cation Name: Noninvasive blood pressure measurement system Predicate Devices: BCI 6004 NIBP Monitor (K970801) BCI 6004 Monitor with Temperature Option, 510(k) pending (K983796) BCI 6200 Vital Signs Monitor (K953415) New Device Description: The BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monito… | 1999 |
| * | K953415 | 6200 Vital Signs MonitorSummary page 1…measurement system Predicate Devices: BCI 6004 NIBP Monitor (K970801) BCI 6004 Monitor with Temperature Option, 510(k) pending (K983796) BCI 6200 Vital Signs Monitor (K953415) New Device Description: The BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional oximeter, electronic th… | 1995 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2008 | Not classified | Z-1649-2008 | Employee error | Due to a component that may be installed backwards, the device may turn off or may immediately reset. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
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…
Read the full statement (166 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984618 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984618: Bci Mini-Torr Plus, Model 6004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984618
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026