510(k) Report

510(k) · Cleared

Cleared

Bci Autocon 3304 Digital Pulse Oximeter

K070732510(k) TraditionalCleared Jul 9, 2007116-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

Smiths Medical Pm, Inc. · DQA Oximeter

Cleared on Jul 9, 2007 as substantially equivalent to K962156 (Bci Intl., Inc., 1996) after a 116-day review. Its family tree reaches back 1 generation to 1996. 28 later devices descend from it.

Decided
Jul 9, 2007
Review
116 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
1

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

Descendants, by year cleared 2009: 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
Descendants, by generation 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 deviceK070732 Bci Autocon 3304 Digital Pulse OximeterSmiths Medical Pm, Inc. · 2007
  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)K070732Bci Autocon 3304 Digital Pulse OximeterSmiths Medical Pm, Inc.2007—
+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—

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 K070732, 1996–2026Source: 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), 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K9621563304 Pulse Oximeter
Summary page 1
…304 Digital Pulse Oximeter Commnon/Classiflcation Name: Pulse Oximeter Predicate Devices: BCI® Autocorr Tm 3304 Digital Pulse Oximeter (K962156) Device Description: The subject device is the same as the legally marketed predicate device BCL® 3304 Autocorrrhl Digital Puls…
Bci Intl., Inc.1996—

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?

  • Its one ancestor has no 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. 2007, this device’s year, is highlighted.

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 3304 provides fast, reliable SpO2, 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 patient monitoring with adjustable alarms limits as well as visible and audible alarm signals.

Indications for use as stated in the FDA summary.

Also cleared against K962156

7 other devices cite the same predicate.

  • 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
  • K9914103402 Handheld Pulse OximeterBci Intl., Inc. · 1999

More from Smiths Medical Pm, Inc.

5 FDA decisions under this applicant name. See the company

  • K083557Bci WW1030 Pulse OximeterSmiths Medical Pm, Inc. · 2009
  • K090205Bci WW1021 PC ApplicationSmiths Medical Pm, Inc. · 2009
  • K083787Bci WW1000 Pulse Oximeter, Model WW1000Smiths Medical Pm, Inc. · 2009
  • K083705Bci WW1020 Pulse Oximeter, Model WW1020Smiths Medical Pm, Inc. · 2009

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/K070732 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070732: Bci Autocon 3304 Digital 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/K070732

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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