510(k) · Cleared
ClearedBci WW1000 Pulse Oximeter, Model WW1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Pm, Inc. · DQA Oximeter
Cleared on Apr 15, 2009 as substantially equivalent to K040214 (Masimo Corp., 2004) and 2 other predicates after a 117-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Apr 15, 2009
- Review
- 117 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). No later device cites it as a predicate yet.
- Root · 3 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 2 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
- 1 generation backK040214 Modification to: Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2004
- This deviceK083787 Bci WW1000 Pulse Oximeter, Model WW1000Smiths Medical Pm, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo… | Masimo Corp. | 2000 | — |
| −2 | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2003 | — |
| −1 | K040214 | Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2004 | — |
| 0 (this device) | K083787 | Bci WW1000 Pulse Oximeter, Model WW1000 | Smiths Medical Pm, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
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 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040214 | Modification 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)… | 2004 |
| * | K070732 | Bci Autocon 3304 Digital Pulse OximeterSummary page 1…I) 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 this… | 2007 |
| * | K991410 | 3402 Handheld Pulse OximeterSummary 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 WW1 000 pulse oximeter. The BC… | 1999 |
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?
- 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.
- 4 other devices also cite its predicate K040214.
How does its category compare?
All DQA devicesDQA 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The BCI® model WW1000 handheld 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 infant to adult. It can be used on patients with low perfusion. The WW1000 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.
https://510kreport.com/device/K083787 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083787: Bci WW1000 Pulse Oximeter, Model WW1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083787
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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