510(k) Report

510(k) · Cleared

Cleared

3301 Pulse Oximeter

K943404510(k) TraditionalCleared Oct 13, 199491-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 Oct 13, 1994 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 44 later devices descend from it.

Decided
Oct 13, 1994
Review
91 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
0

44 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2005: 1 descendant cleared2006: 1 descendant cleared2013: 1 descendant cleared2009: 2 descendants cleared2011: 2 descendants cleared2007: 1 descendant cleared2019: 1 descendant cleared2024: 7 descendants cleared2017: 2 descendants cleared2020: 6 descendants cleared2014: 1 descendant cleared2023: 6 descendants cleared2015: 1 descendant cleared2021: 1 descendant cleared2022: 3 descendants cleared2025: 5 descendants cleared2026: 2 descendants cleared1990200020102020
  1. This deviceK943404 3301 Pulse OximeterBci Intl., Inc. · 1994
  2. Descendant · cites it directly · 43 of its ownK013171 3420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002
  3. Descendant · 2 generations on · 42 of its ownK043528 SpirotelMir Medical Intl. Research Srl · 2005
  4. Descendant · 3 generations on · 40 of its ownK061712 Spirobank IIMir Medical Intl. Research Srl · 2006
  5. Descendant · 4 generations on · 33 of its ownK072979 Spirobank GMir Medical Intl. Research Srl · 2007
  6. Descendant · 5 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2002: 12005: 12006: 12007: 12009: 22011: 22013: 12014: 12015: 12017: 22019: 12020: 62021: 12022: 32023: 62024: 72025: 52026: 2
2002high 7 (2024) · low 0 (2003)2026

Most influential descendants

Showing 5 of 44 · 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
  • K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 5 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K9434043301 Pulse OximeterBci Intl., Inc.1994—
+1K0131713420 Digit Pulse Oximeter, Model 3420Bci, Inc.2002—
+2K043528SpirotelMir Medical Intl. Research Srl2005—
+3K061712Spirobank IIMir Medical Intl. Research Srl2006—
+4K072979Spirobank GMir Medical Intl. Research Srl2007—
+5K191272Wearable Device, Wearable PackageCurrent Health, Ltd.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200510
200610
200710
200920
201120
201310
201410
201510
201720
201910
202060
202110
202230
202360
202470
202550
202620
FIG. 1 — Lineage of K943404, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (44)

See all 44

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K0131713420 Digit Pulse Oximeter, Model 3420Bci, Inc.200243

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 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—

More from Bci Intl., Inc.

20 FDA decisions under this applicant name. See the company

  • K991086Capnocheck II, Model 8400Bci Intl., Inc. · 19991 recall
  • K9914103402 Handheld Pulse OximeterBci Intl., Inc. · 1999
  • 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

Recent decisions in DQA

The DQA category page

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  • 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/K943404 · printed Nov 5, 2026

Cite this page

510(k) Report. “K943404: 3301 Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943404

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026