510(k) · Cleared
Recalled · 2008Bci 6004 Nibp Monitor with Nellcor Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Aug 18, 2003 as substantially equivalent to K984618 (Bci Intl., Inc., 1999) and 4 other predicates after a 75-day review. Its family tree reaches back 6 generations to 1997. It has been recalled once.
- Decided
- Aug 18, 2003
- Review
- 75 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 6 generations to K962603 (1997). 14 ancestors in all, the oldest K904039 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 2 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 1 generation backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- This deviceK031742 Bci 6004 Nibp Monitor with Nellcor Pulse OximeterBci, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −3 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −2 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −1 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| 0 (this device) | K031742 | Bci 6004 Nibp Monitor with Nellcor Pulse Oximeter | Bci, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K984618 | Bci Mini-Torr Plus, Model 6004Summary page 1…Non-invasive blood pressure monjtor/pulse oximeter Predicate Devices: BCI@6004 NIBP monitor (K984618, K983796, K97080 1) Nellcor@Oxim… | 1999 |
| * | K983796 | 6004 Nibp Monitor with TemperatureSummary page 1…ive blood pressure monjtor/pulse oximeter Predicate Devices: BCI@6004 NIBP monitor (K984618, K983796, K97080 1) Nellcor@Oximax N-550… | 1999 |
| * | K970801 | Bci Model 6004 Nibp Monitor (6004)Summary page 1…oximeter Predicate Devices: BCI@6004 NIBP monitor (K984618, K983796, K97080 1) Nellcor@Oximax N-550 Pulse Oximeter… | 1997 |
| * | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterSummary page 1…The BCI 6004 NIBP monitor with Nellcor pulse oximetry uses the Nellcor MP506 pulse oximetry module. This same module is used in the Nellcor Oximax N-550 Pulse Oximeter (K021090). The Nellcor MP506 board uses the same technology in a very similar design to that found in the Nellcor N-595 Pulse Oximeter. T… | 2002 |
| * | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 6 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K984618.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The 6004 NIBP monitor is a low cost 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 Sp02, optional oralhectal temperature, and/or integral printer. The device will provide NIBP measurements on patients ranging from neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and…
Read the full statement (199 words)
The 6004 NIBP monitor is a low cost 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 Sp02, optional oralhectal temperature, and/or integral printer. The device will provide NIBP measurements on patients ranging from neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. An LED indicator illuminates when the monitor is configured for NIBP neonate mode. The BCI oximetry options work with all BCI oximetry sensors when providing SpOl and pulse rate on all patients from neonate to adult in both NIBP adult and neonate mode. The Nellcor oximetry option provides SpOl and pulse rate data on adult patients using the Nellcor DS lOOA sensor. The electronic thermometry option is intended for intermittent “spot checks” of oral or rectal temperature for patients neonate through adult and requires WelchAl lyn thermometry probes and probe covers. The temperature option works for all patients in NIBP adult or neonate mode. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031742: Bci 6004 Nibp Monitor with Nellcor Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031742
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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