510(k) · Cleared
ClearedIM2001 Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imagyn Medical Technologies, Inc. · DQA Oximeter
Cleared on Mar 7, 2003 as substantially equivalent to K991823 (Nellcor Puritan Bennett, Inc., 1999) and 1 other predicate after a 570-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Mar 7, 2003
- Review
- 570 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K962603 (1997). 6 ancestors in all, the oldest K955642 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 1 generation backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- This deviceK012706 IM2001 Pulse OximeterImagyn Medical Technologies, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK032831 Pro 2 Monitor, Pro 2 Sensor, PRO2 Holder, PRO2 Neonate Holder…Conmed Corporation · 2004
- Descendant · 2 generations on · 0 of its ownK061112 Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-MConmed Corporation · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −1 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| 0 (this device) | K012706 | IM2001 Pulse Oximeter | Imagyn Medical Technologies, Inc. | 2003 | — |
| +1 | K032831 | Pro 2 Monitor, Pro 2 Sensor, PRO2 Holder, PRO2 Neonate Holder, Models, Pro-… | Conmed Corporation | 2004 | — |
| +2 | K061112 | Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-M | Conmed Corporation | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991823 | N-395 Pulse Oximeter, Model N-395Summary page 1…ation No. 870.2700) and they are reviewed by the Cardiovascular Panel. Predicate Device: N-395 Pulse Oximeter (Nellcor Puritan Bennett, Inc) cleared under K991823 and K993637 when operates with its RS-10 sensor (Nellcor Puritan Bennett, Inc) cleared under K904039.… | 1999 |
| * | K993637 | N-395 Pulse Oximeter, with Extended Device ClaimsSummary page 1…0.2700) and they are reviewed by the Cardiovascular Panel. Predicate Device: N-395 Pulse Oximeter (Nellcor Puritan Bennett, Inc) cleared under K991823 and K993637 when operates with its RS-10 sensor (Nellcor Puritan Bennett, Inc) cleared under K904039.… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032831 | Pro 2 Monitor, Pro 2 Sensor, PRO2 Holder, PRO2 Neonate Holder, Models, Pro- 200… | 2004 | 1 |
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 6 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K032831 (Conmed Corporation, 2004) has gone furthest, with 1 descendant of its own.
- 20 other devices also cite its predicate K991823.
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?
The IM2001 Pulse Oximeter is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate. For use with pediatric and adult population, in hospitals, hospital-type facilities and intra-hospital transport environment. For prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K012706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012706: IM2001 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/K012706
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026