510(k) · Cleared
Cleared3304 Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bci Intl., Inc. · DQA Oximeter
Cleared on Aug 28, 1996 after an 85-day review. The FDA summary names its predicate without a number. 40 later devices descend from it.
- Decided
- Aug 28, 1996
- Review
- 85 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 8 citing it directly.
- This deviceK962156 3304 Pulse OximeterBci Intl., Inc. · 1996
- Descendant · cites it directly · 28 of its ownK070732 Bci Autocon 3304 Digital Pulse OximeterSmiths Medical Pm, Inc. · 2007
- Descendant · cites it directly · 28 of its ownK991410 3402 Handheld Pulse OximeterBci Intl., Inc. · 1999
- Descendant · 2 generations on · 25 of its ownK083705 Bci WW1020 Pulse Oximeter, Model WW1020Smiths Medical Pm, Inc. · 2009
- Descendant · 3 generations on · 22 of its ownK100077 Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model…Solaris Medical Technology, Inc. · 2010
- Descendant · 4 generations on · 14 of its ownK142832 Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K070732Bci Autocon 3304 Digital Pulse OximeterSmiths Medical Pm, Inc. · 2007 · cites it directly28descendants
- K9914103402 Handheld Pulse OximeterBci Intl., Inc. · 1999 · cites it directly28descendants
- K083705Bci WW1020 Pulse Oximeter, Model WW1020Smiths Medical Pm, Inc. · 2009 · 2 generations on25descendants
- K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc. · 2010 · 3 generations on22descendants
- K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962156 | 3304 Pulse Oximeter | Bci Intl., Inc. | 1996 | — |
| +1 | K070732 | Bci Autocon 3304 Digital Pulse Oximeter | Smiths Medical Pm, Inc. | 2007 | — |
| +1 | K991410 | 3402 Handheld Pulse Oximeter | Bci Intl., Inc. | 1999 | — |
| +2 | K083705 | Bci WW1020 Pulse Oximeter, Model WW1020 | Smiths Medical Pm, Inc. | 2009 | — |
| +3 | K100077 | Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103 | Solaris Medical Technology, Inc. | 2010 | — |
| +4 | K142832 | Unimed Disposable and Reusable SPO2 Sensors | Unimed Medical Supplies, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | — | BCI 3301 Oximeter Named without a submission number | |
| * | — | BCI 3302 Oximeter Named without a submission number | |
| * | — | BCI 3100 Oximeter Named without a submission number |
What descends from it? (40)
See all 408 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070732 | Bci Autocon 3304 Digital Pulse Oximeter | 2007 | 28 |
| K991410 | 3402 Handheld Pulse Oximeter | 1999 | 28 |
| K041522 | Flexi-Stat Disposable Adhesive SPO2 Sensors | 2004 | 2 |
| K041647 | Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible)… | 2004 | 2 |
| K971946 | NPB-190 Pulse Oximeter (NPB-190) | 1997 | 1 |
| K041964 | Mediaid Reusable Finger Clip SPO2 Sensors and Disposable Non-Adhesive Sensors and… | 2004 | 0 |
| K041644 | Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible)… | 2004 | 0 |
| K020350 | Bci 3180 Pulse Oximeter | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070732 (Smiths Medical Pm, Inc., 2007) has gone furthest, with 28 descendants of its own.
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 3304 provides fast, reliable SpO,, pulse rate and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport and in the home. The oximeter will operate accurately over an ambient temperature range of 32 to 104° F (0 to 40° C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The oximeter permits continuous 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/K962156 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962156: 3304 Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962156
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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