510(k) · Cleared
Recalled · 2008Bci Model 6004 Nibp Monitor (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 Nov 12, 1997 after a 253-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled once.
- Decided
- Nov 12, 1997
- Review
- 253 days
- Class
- Class II
- Product code
- DXN
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK970801 Bci Model 6004 Nibp Monitor (6004)Bci Intl., Inc. · 1997
- Descendant · cites it directly · 2 of its ownK984618 Bci Mini-Torr Plus, Model 6004Bci Intl., Inc. · 1999 · Recalled
- Descendant · cites it directly · 2 of its ownK982279 Vital Signs Monitor; Advisor Model # Bci 9200Bci Intl., Inc. · 1998 · Recalled
- Descendant · 2 generations on · 1 of its ownK030407 Advisor, Model 9200Bci, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK160667 Anybattery C2 Rechargeable BatteryAnybattery, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK061931 Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models…Solaris Medical Technology, Inc. · 2007
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K984618Bci Mini-Torr Plus, Model 6004Bci Intl., Inc. · 1999 · cites it directly2descendants
- K982279Vital Signs Monitor; Advisor Model # Bci 9200Bci Intl., Inc. · 1998 · cites it directly2descendants
- K030407Advisor, Model 9200Bci, Inc. · 2003 · 2 generations on1descendant
- K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc. · 2017 · 2 generations on0descendants
- K061931Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103…Solaris Medical Technology, Inc. · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970801 | Bci Model 6004 Nibp Monitor (6004) | Bci Intl., Inc. | 1997 | — |
| +1 | K984618 | Bci Mini-Torr Plus, Model 6004 | Bci Intl., Inc. | 1999 | 1 |
| +1 | K982279 | Vital Signs Monitor; Advisor Model # Bci 9200 | Bci Intl., Inc. | 1998 | 40 |
| +2 | K030407 | Advisor, Model 9200 | Bci, Inc. | 2003 | 43 |
| +2 | K160667 | Anybattery C2 Rechargeable Battery | Anybattery, Inc. | 2017 | — |
| +3 | K061931 | Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and… | Solaris Medical Technology, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 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? (1)
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.
What descends from it? (6)
3 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?
- Of its descendants, K984618 (Bci Intl., Inc., 1999) has gone furthest, with 2 descendants of its own.
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 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…
Read the full statement (119 words)
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.
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/K970801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970801: Bci Model 6004 Nibp Monitor (6004).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970801
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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