510(k) · Cleared
ClearedBci 3401 Handheld 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 Mar 25, 1998 after a 29-day review. The FDA summary names its predicate without a number. 74 later devices descend from it.
- Decided
- Mar 25, 1998
- Review
- 29 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
74 later devices descend from it, 3 citing it directly.
- This deviceK980714 Bci 3401 Handheld Pulse OximeterBci Intl., Inc. · 1998
- Descendant · cites it directly · 43 of its ownK013171 3420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002
- Descendant · 2 generations on · 42 of its ownK043528 SpirotelMir Medical Intl. Research Srl · 2005
- Descendant · 3 generations on · 40 of its ownK061712 Spirobank IIMir Medical Intl. Research Srl · 2006
- Descendant · 4 generations on · 33 of its ownK072979 Spirobank GMir Medical Intl. Research Srl · 2007
- Descendant · cites it directly · 28 of its ownK991410 3402 Handheld Pulse OximeterBci Intl., Inc. · 1999
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K0131713420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002 · cites it directly43descendants
- K043528SpirotelMir Medical Intl. Research Srl · 2005 · 2 generations on42descendants
- K061712Spirobank IIMir Medical Intl. Research Srl · 2006 · 3 generations on40descendants
- K072979Spirobank GMir Medical Intl. Research Srl · 2007 · 4 generations on33descendants
- K9914103402 Handheld Pulse OximeterBci Intl., Inc. · 1999 · cites it directly28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980714 | Bci 3401 Handheld Pulse Oximeter | Bci Intl., Inc. | 1998 | — |
| +1 | K013171 | 3420 Digit Pulse Oximeter, Model 3420 | Bci, Inc. | 2002 | — |
| +2 | K043528 | Spirotel | Mir Medical Intl. Research Srl | 2005 | — |
| +3 | K061712 | Spirobank II | Mir Medical Intl. Research Srl | 2006 | — |
| +4 | K072979 | Spirobank G | Mir Medical Intl. Research Srl | 2007 | — |
| +1 | K991410 | 3402 Handheld Pulse Oximeter | Bci Intl., Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 10 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 11 | 0 |
| 2026 | 4 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | BCI 3301 Handheld Pulse Oximeter Named without a submission number |
What descends from it? (74)
See all 743 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013171 (Bci, Inc., 2002) has gone furthest, with 43 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 BCI 3401 Pulse Oximeter is a handheld, low cost monitor for spot checking or attended monitoring of SpO,, pulse rate and pulse strength. The 3401 is a battery powered pulse oximeter with an optional built-in printer. It may be used in the hospital or clinical environment, and during emergency land. The oximeter will operate accurately over an ambient temperature range of 32 to 131°F (0 to 55°C). The oximeter works with all BCI oximetry sensors providing SpO2 and pulse rate on all patients from neonate to adult.
This device is not intended for continuous patient monitoring. There are no audible or visable patient alarms. The device is not intended for home use.
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/K980714 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980714: Bci 3401 Handheld 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/K980714
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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