510(k) Report

510(k) · Cleared

Cleared

Bci 3178 Pediatric Pulse Oximetry Sensor

K020739510(k) TraditionalCleared Jun 3, 200289-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, Inc. · DQA Oximeter

Cleared on Jun 3, 2002 as substantially equivalent to K893877 (Biochem International, Inc., 1989) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1989.

Decided
Jun 3, 2002
Review
89 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K893877 (1989). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1990: 1 other ancestorK893877 · Biochem 3100 Oximeter · Biochem International, Inc. · 19891985199019952000
Other ancestors, by generation 1 generation back: 1 other ancestor K893877 · Biochem 3100 Oximeter · Biochem International, Inc. · 19890
  1. Root · 1 generation backK893877 Biochem 3100 OximeterBiochem International, Inc. · 1989
  2. This deviceK020739 Bci 3178 Pediatric Pulse Oximetry SensorBci, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K893877Biochem 3100 OximeterBiochem International, Inc.1989—
0 (this device)K020739Bci 3178 Pediatric Pulse Oximetry SensorBci, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
FIG. 1 — Lineage of K020739, 1989–2002Source: 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? (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
*K893877Biochem 3100 Oximeter
Summary page 1
…Pulse Oximeter Sensor Predicate Devices: BCI 3044 Reusable Pulse Oximetry Sensor (K893877) BC1 3025 Reusable Infant Pulse Oximetry…
Biochem International, Inc.1989—
*K901861Biochem 9100 Multigas Monitor
Summary page 1
…(K893877) BC1 3025 Reusable Infant Pulse Oximetry Sensor (K901861) BCI 3043 Reusable Universal ‘‘Y Pulse Oximetry…
Biochem International, Inc.1990—

Also cleared against K893877: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
  • 2 other devices also cite its predicate K893877.

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 BCI 3178 Pediatric Pulse Oximetry Sensor is a reusable finger sensor that can be used to non-invasively measure oxygen saturation (SpO2), pulse rate and plethysmographic pulse waves. It's performance was validated with the BCI 3304 pulse oximeter. The BCI 3178 Pediatric Pulse Oximetry Sensor will provide reliable spot check measurements on patients weighing from 10 to 100 lbs (5 - 45 kg). The sensor is not intended for prolonged use.

Indications for use as stated in the FDA summary.

Also cleared against K893877

2 other devices cite the same predicate.

  • K043463Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH · 2005
  • K020350Bci 3180 Pulse OximeterBci, Inc. · 20022 recalls

More from Bci, Inc.

13 FDA decisions under this applicant name. See the company

  • K030407Advisor, Model 9200Bci, Inc. · 200343 recalls
  • K031742Bci 6004 Nibp Monitor with Nellcor Pulse OximeterBci, Inc. · 20031 recall
  • K020350Bci 3180 Pulse OximeterBci, Inc. · 20022 recalls
  • K013862Bci 1621 Oximetry Data Management ProgramBci, Inc. · 2002
  • K0131713420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002

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/K020739 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020739: Bci 3178 Pediatric Pulse Oximetry Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020739

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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