510(k) Report

510(k) · Cleared

Cleared

3402 Handheld Pulse Oximeter

K991410510(k) TraditionalCleared Jun 9, 199948-day reviewClass II21 CFR 870.2700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bci Intl., Inc. · DQA Oximeter

Cleared on Jun 9, 1999 as substantially equivalent to K962156 (Bci Intl., Inc., 1996) and 1 other predicate after a 48-day review. Its family tree reaches back 1 generation to 1996. 28 later devices descend from it.

Decided
Jun 9, 1999
Review
48 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K962156 (1996). 2 ancestors in all. 28 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2009: 3 descendants cleared2011: 1 descendant cleared2010: 2 descendants cleared2015: 1 descendant cleared2018: 4 descendants cleared2017: 1 descendant cleared2016: 1 descendant cleared2019: 2 descendants cleared2025: 6 descendants cleared2020: 4 descendants cleared2026: 2 descendants cleared2024: 1 descendant clearedK962156 · 3304 Pulse Oximeter · Bci Intl., Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 13 descendants5 generations forward: 5 descendants K962156 · 3304 Pulse Oximeter · Bci Intl., Inc. · 19960+5
  1. Root · 1 generation backK962156 3304 Pulse OximeterBci Intl., Inc. · 1996
  2. This deviceK991410 3402 Handheld Pulse OximeterBci Intl., Inc. · 1999
  3. Descendant · cites it directly · 25 of its ownK083705 Bci WW1020 Pulse Oximeter, Model WW1020Smiths Medical Pm, Inc. · 2009
  4. Descendant · 2 generations on · 22 of its ownK100077 Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model…Solaris Medical Technology, Inc. · 2010
  5. Descendant · 3 generations on · 14 of its ownK142832 Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015
  6. Descendant · 3 generations on · 5 of its ownK153184 Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd. · 2017
  7. Descendant · 4 generations on · 1 of its ownK242580 Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable…Unimed Medical Supplies, Inc. · 2025

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2009: 32010: 22011: 12015: 12016: 12017: 12018: 42019: 22020: 42024: 12025: 62026: 2
2009high 6 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 28 · See all
  • K083705Bci WW1020 Pulse Oximeter, Model WW1020Smiths Medical Pm, Inc. · 2009 · cites it directly25descendants
  • K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc. · 2010 · 2 generations on22descendants
  • K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015 · 3 generations on14descendants
  • K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd. · 2017 · 3 generations on5descendants
  • K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc. · 2025 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K9621563304 Pulse OximeterBci Intl., Inc.1996—
0 (this device)K9914103402 Handheld Pulse OximeterBci Intl., Inc.1999—
+1K083705Bci WW1020 Pulse Oximeter, Model WW1020Smiths Medical Pm, Inc.2009—
+2K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.2010—
+3K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.2015—
+3K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.2017—
+4K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger…Unimed Medical Supplies, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200930
201020
201110
201510
201610
201710
201840
201920
202040
202410
202560
202620
FIG. 1 — Lineage of K991410, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K9621563304 Pulse Oximeter
Summary page 1
…pared: April 5, 1999 Proprietary Name: BCI Digital Handheld Oximeter (model 3402) Common/Classification Name: Pulse Oximeter Predijcate Devices: BCI 3304 Pulse Oximeter (K962156) BCI 3401 Handheld Oximeter (K980714) New Device Description: The BCI 3402 Digital Handheld Oximeter monitor is an updated ver…
Bci Intl., Inc.1996—
*K980714Bci 3401 Handheld Pulse Oximeter
Summary page 1
…BCI Digital Handheld Oximeter (model 3402) Common/Classification Name: Pulse Oximeter Predijcate Devices: BCI 3304 Pulse Oximeter (K962156) BCI 3401 Handheld Oximeter (K980714) New Device Description: The BCI 3402 Digital Handheld Oximeter monitor is an updated version of an existing pulse oximeter leg…
Bci Intl., Inc.1998—

Also cleared against K962156: 7 other devices →

What descends from it? (28)

See all 28

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083705Bci WW1020 Pulse Oximeter, Model WW1020Smiths Medical Pm, Inc.200925
K083557Bci WW1030 Pulse OximeterSmiths Medical Pm, Inc.20090
K083787Bci WW1000 Pulse Oximeter, Model WW1000Smiths Medical Pm, Inc.20090

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 2 ancestors has a recall.
  • Of its descendants, K083705 (Smiths Medical Pm, Inc., 2009) has gone furthest, with 25 descendants of its own.
  • 7 other devices also cite its predicate K962156.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
2007high 32 (2018) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQA

399in 2025

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

What is it indicated for?

The 3402 Digital Handheld Oximeter is a handheld, low cost pulse oximeter for spot checking or continuous roonitoring of SpO,, pulse rate, and pulse strength. It may be used in all critical environments, including clinical and EMS (Emergency Medical Services), patient ground transport, and for use in sleep screening or in the home. The oximetry parameter works with all BCI oximetry sensors, providing SpO, and pulse rate on all patients from neonate to adult. The 3402 Digital Handheld Oximeter permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals.

The BCI 3402 is not designed or intended to be used as an apnea monitor.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K962156

7 other devices cite the same predicate.

  • K070732Bci Autocon 3304 Digital Pulse OximeterSmiths Medical Pm, Inc. · 2007
  • K041522Flexi-Stat Disposable Adhesive SPO2 SensorsElekon Industries U.S.A., Inc. · 2004
  • K041964Mediaid Reusable Finger Clip SPO2 Sensors and Disposable Non-Adhesive Sensors and Adhesive SPO2 SensorsMediaid, Inc. · 2004
  • K041647Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible), (Datex-Compatible)Elekon Industries U.S.A., Inc. · 2004
  • K041644Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible), (Datex-Compatible)Elekon Industries U.S.A., Inc. · 2004
  • K020350Bci 3180 Pulse OximeterBci, Inc. · 20022 recalls

More from Bci Intl., Inc.

20 FDA decisions under this applicant name. See the company

  • K991086Capnocheck II, Model 8400Bci Intl., Inc. · 19991 recall
  • K984618Bci Mini-Torr Plus, Model 6004Bci Intl., Inc. · 19991 recall
  • K9837966004 Nibp Monitor with TemperatureBci Intl., Inc. · 19991 recall
  • K982279Vital Signs Monitor; Advisor Model # Bci 9200Bci Intl., Inc. · 199840 recalls
  • K981939Autocorr Plus; 3404 Oximeter/Ecg MonitorBci Intl., Inc. · 19982 recalls

Recent decisions in DQA

The DQA category page

  • K260490Ninenovo Blood Oxygen Ring…Shenzhen Ninenovo Technology Limited · 2026
  • K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH · 2026
  • K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
  • K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026

https://510kreport.com/device/K991410 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991410: 3402 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/K991410

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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