510(k) · Cleared
ClearedModel 2000 Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivy Biomedical Systems, Inc. · DQA Oximeter
Cleared on Oct 22, 1998 as substantially equivalent to K973887 (Masimo Corp., 1998) after a 118-day review. Its family tree reaches back 2 generations to 1997. 6 of the 819 devices in its family, counting itself, have a Class I recall. 816 later devices descend from it.
- Decided
- Oct 22, 1998
- Review
- 118 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K962603 (1997). 816 later devices descend from it, 3 citing it directly. 6 of the 819 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 1 generation backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- This deviceK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- Descendant · cites it directly · 785 of its ownK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- Descendant · cites it directly · 715 of its ownK993637 N-395 Pulse Oximeter, with Extended Device ClaimsNellcor Puritan Bennett, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 548 of its ownK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 426 of its ownK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- Descendant · 4 generations on · 290 of its ownK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
Showing 5 of 816 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 816 · See all- K991823N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999 · cites it directly785descendants
- K993637N-395 Pulse Oximeter, with Extended Device ClaimsNellcor Puritan Bennett, Inc. · 1999 · cites it directly715descendants
- K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Nellcor Puritan Bennett, Inc. · 2002 · 2 generations on548descendants
- K021090Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002 · 3 generations on426descendants
- K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003 · 4 generations on290descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −1 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| 0 (this device) | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| +1 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| +1 | K993637 | N-395 Pulse Oximeter, with Extended Device Claims | Nellcor Puritan Bennett, Inc. | 1999 | 1 |
| +2 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| +3 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| +4 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 8 | 0 |
| 2003 | 10 | 0 |
| 2004 | 23 | 0 |
| 2005 | 19 | 0 |
| 2006 | 28 | 0 |
| 2007 | 14 | 1 |
| 2008 | 24 | 0 |
| 2009 | 38 | 1 |
| 2010 | 37 | 1 |
| 2011 | 34 | 0 |
| 2012 | 38 | 0 |
| 2013 | 36 | 1 |
| 2014 | 36 | 2 |
| 2015 | 42 | 0 |
| 2016 | 34 | 0 |
| 2017 | 37 | 0 |
| 2018 | 42 | 0 |
| 2019 | 45 | 0 |
| 2020 | 36 | 0 |
| 2021 | 25 | 0 |
| 2022 | 44 | 0 |
| 2023 | 44 | 0 |
| 2024 | 37 | 0 |
| 2025 | 50 | 0 |
| 2026 | 31 | 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.
6 devices in this family have a Class I recall. 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and CablesSummary page 1…ulse Oximeter Common Name: Pulse Oximeter Classification Name: Oximeter (74DQA) Substantially Equivalent Devices: Masimo SET® MS-1P Pulse Oximeter and accessories 510K# K973887. Description of Model 2000 Pulse Oximeter The Model 2000 pulse oximeter is a device consisting of the Masimo SET® technology (l… | 1998 |
What descends from it? (816)
See all 8163 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093261MOVESThornhill Research, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
- K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 7 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 9 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K991823 (Nellcor Puritan Bennett, Inc., 1999) has gone furthest, with 785 descendants of its own.
- 1 other device also cites its predicate K973887.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Model 2000 Pulse Oximeter is indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO₂) and pulse rates for adult, pediatric and neonatal patients in a hospital and mobile environment (within the hospital).
In addition the Model 2000 is indicated for the continuous non-invasive monitoring of arterial oxygen saturation (SpO₂) and pulse rates for adults during patient motion conditions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982255: Model 2000 Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982255
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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