510(k) Report

510(k) · Cleared

Recalled · 2010

Bci 3180 Pulse Oximeter

K020350510(k) TraditionalCleared Apr 30, 200285-day reviewClass II21 CFR 870.2700Recalls 2

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 Apr 30, 2002 as substantially equivalent to K893877 (Biochem International, Inc., 1989) and 2 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1989. It has been recalled 2 times.

Decided
Apr 30, 2002
Review
85 days
Class
Class II
Product code
DQA
Recalls
2
Predicates
3

Its longest line of descent runs back 1 generation to K893877 (1989). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1996: 1 other ancestorK893877 · Biochem 3100 Oximeter · Biochem International, Inc. · 19891985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K893877 · Biochem 3100 Oximeter · Biochem International, Inc. · 19890
  1. Root · 1 generation backK893877 Biochem 3100 OximeterBiochem International, Inc. · 1989
  2. This deviceK020350 Bci 3180 Pulse OximeterBci, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K893877Biochem 3100 OximeterBiochem International, Inc.1989—
0 (this device)K020350Bci 3180 Pulse OximeterBci, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
FIG. 1 — Lineage of K020350, 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
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What was it cleared against? (3)

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
…y Affairs Prepared: January 30, 2002 Proprietary Name: BCI 3180 Pulse Oximeter Common/Classification Name: Pulse Oximeter Predicate Devices: BCI 3100 Pulse Oximeter (K893877) BCI 3304 Pulse Oximeter (K962156) BCI 3401 Pulse Oximeter (K980714) New Device Description: The BCI 3180 pulse oximeter is a…
Biochem International, Inc.1989—
*K9621563304 Pulse Oximeter
Summary page 1
…02 Proprietary Name: BCI 3180 Pulse Oximeter Common/Classification Name: Pulse Oximeter Predicate Devices: BCI 3100 Pulse Oximeter (K893877) BCI 3304 Pulse Oximeter (K962156) BCI 3401 Pulse Oximeter (K980714) New Device Description: The BCI 3180 pulse oximeter is a new monitor with the same parameter…
Bci Intl., Inc.1996—
*K980714Bci 3401 Handheld Pulse Oximeter
Summary page 1
…se Oximeter Common/Classification Name: Pulse Oximeter Predicate Devices: BCI 3100 Pulse Oximeter (K893877) BCI 3304 Pulse Oximeter (K962156) BCI 3401 Pulse Oximeter (K980714) New Device Description: The BCI 3180 pulse oximeter is a new monitor with the same parameters as existing devices legally mark…
Bci Intl., Inc.1998—

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)

Recalls of this device

DateClassRecallRoot causeReason
Jan 15, 2010Not classifiedZ-0919-2010Nonconforming Material/ComponentSmiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or…
Feb 27, 2008Not classifiedZ-1619-2008Vendor change controlThe Smith Medical PM, Inc. BCI 3180 Pulse Oximeter tantalum capacitors C38, C72, C74, and C98 were installed backwards during assembly at the board manufacturer. This exposes the components to reverse polarity voltages that may lead to…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 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 3180 pulse oximeter is indicated for continuous petient monitoring of patient SpO2, pulse rate, and pulse strength measurements. It is intended for the hospital or clinical environment and during emergency land transport. It is intended for use in critical environments, including ventilatory applications, patient transport, and anesthesia. It is not intended for use in the home. The pulse oximeter is intended for use with all BCI pulse oximetry sensors, providing SpO2 and pulse rate measurements on all patients from neonate to adult.

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 K893877

2 other devices cite the same predicate.

  • K043463Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH · 2005
  • K020739Bci 3178 Pediatric Pulse Oximetry SensorBci, Inc. · 2002

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
  • K020739Bci 3178 Pediatric Pulse Oximetry SensorBci, Inc. · 2002
  • 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/K020350 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020350: Bci 3180 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/K020350

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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