510(k) Report

510(k) · Cleared

Cleared

Bci WW1020 Pulse Oximeter, Model WW1020

K083705510(k) TraditionalCleared Apr 9, 2009115-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 Apr 9, 2009 as substantially equivalent to K040214 (Masimo Corp., 2004) and 2 other predicates after a 115-day review. Its family tree reaches back 3 generations to 2000. 25 later devices descend from it.

Decided
Apr 9, 2009
Review
115 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K000126 (2000). 7 ancestors in all, the oldest K962156 (1996). 25 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor2011: 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 clearedK000126 · Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric Disposable Sensor, Masimo Lno-PDT-Pedia · Masimo Corp. · 2000K031330 · Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables · Masimo Corp. · 2003K040214 · Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables · Masimo Corp. · 20041995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 13 descendants4 generations forward: 5 descendants K040214 · Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables · Masimo Corp. · 2004K031330 · Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables · Masimo Corp. · 2003K000126 · Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric Disposable Sensor, Masimo Lno-PDT-Pedia · Masimo Corp. · 20000
  1. Root · 3 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
  2. 2 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
  3. 1 generation backK040214 Modification to: Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2004
  4. This deviceK083705 Bci WW1020 Pulse Oximeter, Model WW1020Smiths Medical Pm, Inc. · 2009
  5. Descendant · cites it directly · 22 of its ownK100077 Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model…Solaris Medical Technology, Inc. · 2010
  6. Descendant · 2 generations on · 14 of its ownK142832 Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015
  7. Descendant · 2 generations on · 5 of its ownK153184 Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd. · 2017
  8. Descendant · 3 generations on · 1 of its ownK242580 Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable…Unimed Medical Supplies, Inc. · 2025
  9. Descendant · 3 generations on · 1 of its ownK202851 Spo2 SensorJkh USA, LLC · 2020

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2010: 22011: 12015: 12016: 12017: 12018: 42019: 22020: 42024: 12025: 62026: 2
2010high 6 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 25 · See all
  • K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc. · 2010 · cites it directly22descendants
  • K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015 · 2 generations on14descendants
  • K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd. · 2017 · 2 generations on5descendants
  • K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc. · 2025 · 3 generations on1descendant
  • K202851Spo2 SensorJkh USA, LLC · 2020 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K000126Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp.2000—
−2K031330Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop…Masimo Corp.2003—
−1K040214Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop…Masimo Corp.2004—
0 (this device)K083705Bci WW1020 Pulse Oximeter, Model WW1020Smiths Medical Pm, Inc.2009—
+1K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.2010—
+2K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.2015—
+2K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.2017—
+3K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger…Unimed Medical Supplies, Inc.2025—
+3K202851Spo2 SensorJkh USA, LLC2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
199910
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201110
201510
201610
201710
201840
201920
202040
202410
202560
202620
FIG. 1 — Lineage of K083705, 2000–2026Source: 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? (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
*K040214Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…
Summary page 1
…DQA Regulation Number: 870.2700 (Class II) Predicate Devices: Masimo SET Radical pulse oximeter (K040214) BCI® Autocorr model 3304 pulse oximeter (K070732)…
Masimo Corp.2004—
*K070732Bci Autocon 3304 Digital Pulse Oximeter
Summary page 1
…Predicate Devices: Masimo SET Radical pulse oximeter (K040214) BCI® Autocorr model 3304 pulse oximeter (K070732) BCI® MiniCorr model 3402 pulse oximeter (K991410) Device Description: The aim of…
Smiths Medical Pm, Inc.2007—
*K9914103402 Handheld Pulse Oximeter
Summary page 1
…BCI® Autocorr model 3304 pulse oximeter (K070732) BCI® MiniCorr model 3402 pulse oximeter (K991410) Device Description: The aim of this submission is to obtain market clearance for the BCI model WW1020 pulse oximeter.…
Bci Intl., Inc.1999—

Also cleared against K040214: 4 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.201022
K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110
K093080Metaphor Metabolic MonitorTreymed, Inc.20100

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?

  • The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K100077 (Solaris Medical Technology, Inc., 2010) has gone furthest, with 22 descendants of its own.
  • 4 other devices also cite its predicate K040214.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 BCI® model WW1020 pulse oximeter is intended for spot-checking applications (non-continuous use). It monitors and displays a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians and home users. The intended patient population ranges from neonatal to adult: It can be used on patients with low perfusion or during patient motion. The WW1020 may be used in the hospital or clinical environment, during emergency land transport, and in the home.

Indications for use as stated in the FDA summary.

Also cleared against K040214

4 other devices cite the same predicate.

  • K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012
  • K083557Bci WW1030 Pulse OximeterSmiths Medical Pm, Inc. · 2009
  • K083787Bci WW1000 Pulse Oximeter, Model WW1000Smiths Medical Pm, Inc. · 2009
  • K061204Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006

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
  • K070732Bci Autocon 3304 Digital Pulse OximeterSmiths Medical Pm, Inc. · 2007

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/K083705 · printed Nov 5, 2026

Cite this page

510(k) Report. “K083705: Bci WW1020 Pulse Oximeter, Model WW1020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083705

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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