510(k) · Cleared
Cleared3420 Digit Pulse Oximeter, Model 3420
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Jan 3, 2002 as substantially equivalent to K943404 (Bci Intl., Inc., 1994) and 3 other predicates after a 101-day review. Its family tree reaches back 1 generation to 1994. 43 later devices descend from it.
- Decided
- Jan 3, 2002
- Review
- 101 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K943404 (1994). 4 ancestors in all. 43 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK943404 3301 Pulse OximeterBci Intl., Inc. · 1994
- This deviceK013171 3420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002
- Descendant · cites it directly · 42 of its ownK043528 SpirotelMir Medical Intl. Research Srl · 2005
- Descendant · 2 generations on · 40 of its ownK061712 Spirobank IIMir Medical Intl. Research Srl · 2006
- Descendant · 3 generations on · 33 of its ownK072979 Spirobank GMir Medical Intl. Research Srl · 2007
- Descendant · 4 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
- Descendant · 5 generations on · 8 of its ownK210133 Current Health Monitoring System Gen 2 (G2)Current Health · 2021
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K043528SpirotelMir Medical Intl. Research Srl · 2005 · cites it directly42descendants
- K061712Spirobank IIMir Medical Intl. Research Srl · 2006 · 2 generations on40descendants
- K072979Spirobank GMir Medical Intl. Research Srl · 2007 · 3 generations on33descendants
- K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 4 generations on16descendants
- K210133Current Health Monitoring System Gen 2 (G2)Current Health · 2021 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943404 | 3301 Pulse Oximeter | Bci Intl., Inc. | 1994 | — |
| 0 (this device) | K013171 | 3420 Digit Pulse Oximeter, Model 3420 | Bci, Inc. | 2002 | — |
| +1 | K043528 | Spirotel | Mir Medical Intl. Research Srl | 2005 | — |
| +2 | K061712 | Spirobank II | Mir Medical Intl. Research Srl | 2006 | — |
| +3 | K072979 | Spirobank G | Mir Medical Intl. Research Srl | 2007 | — |
| +4 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | — |
| +5 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 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? (4)
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 |
|---|---|---|---|
| * | K943404 | 3301 Pulse OximeterSummary page 1…Road Waukesha, WI 53186 (262) 542-3100 VP Regulatory Affairs September 21, 2001 BCI® 3420 Digit™ Pulse Oximeter Pulse Oximeter BCI 3301%® Hand-Held Pulse Oximeter (K943404) BCI® 3401 Handheld Pulse Oximeter (K980714) Nonin® Onyx , Model 9500 (K942248, K001085) The BCI® 3420 Digit™ Pulse Oximeter con… | 1994 |
| * | K980714 | Bci 3401 Handheld Pulse OximeterSummary page 1…Regulatory Affairs September 21, 2001 BCI® 3420 Digit™ Pulse Oximeter Pulse Oximeter BCI 3301%® Hand-Held Pulse Oximeter (K943404) BCI® 3401 Handheld Pulse Oximeter (K980714) Nonin® Onyx , Model 9500 (K942248, K001085) The BCI® 3420 Digit™ Pulse Oximeter consists of an pulse oximeter monitor and senso… | 1998 |
| * | K942248 | Miniaturized Finger Clip Pulse OximeterSummary page 1…2001 BCI® 3420 Digit™ Pulse Oximeter Pulse Oximeter BCI 3301%® Hand-Held Pulse Oximeter (K943404) BCI® 3401 Handheld Pulse Oximeter (K980714) Nonin® Onyx , Model 9500 (K942248, K001085) The BCI® 3420 Digit™ Pulse Oximeter consists of an pulse oximeter monitor and sensor contained on a single assembly. T… | 1994 |
| * | K001085 | Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500Summary page 1…® 3420 Digit™ Pulse Oximeter Pulse Oximeter BCI 3301%® Hand-Held Pulse Oximeter (K943404) BCI® 3401 Handheld Pulse Oximeter (K980714) Nonin® Onyx , Model 9500 (K942248, K001085) The BCI® 3420 Digit™ Pulse Oximeter consists of an pulse oximeter monitor and sensor contained on a single assembly. The device… | 2000 |
What descends from it? (43)
See all 431 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043528 | Spirotel | 2005 | 42 |
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?
- None of the 4 ancestors has a recall.
- Of its descendants, K043528 (Mir Medical Intl. Research Srl, 2005) has gone furthest, with 42 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® 3420 Digit™ Pulse Oximeter is a handheld, finger-mounted pulse oximeter that combines the monitor and sensor into one assembly that measures SpO,, pulse rate, and pulse strength. It may be used as a spot check device in the home, hospital or clinical environments, including patient ground transport in clinical and EMS (Emergency Medical Services) settings. The BCI 3420 Digit™ Pulse Oximeter will provide reliable measurements on patients ranging from pediatric to adults.
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/K013171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013171: 3420 Digit Pulse Oximeter, Model 3420.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013171
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026