510(k) · Cleared
ClearedFlexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible), (Datex-Compatible)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekon Industries U.S.A., Inc. · DQA Oximeter
Cleared on Jul 29, 2004 as substantially equivalent to K030930 (Nellcor Puritan Bennett, Inc., 2003) and 3 other predicates after a 42-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jul 29, 2004
- Review
- 42 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K962603 (1997). 13 ancestors in all, the oldest K904039 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 2 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 1 generation backK030930 Oximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-NNellcor Puritan Bennett, Inc. · 2003
- This deviceK041644 Flexi-Stat Disposable Non-Adhesive SPO2 Sensors…Elekon Industries U.S.A., Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −3 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −2 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −1 | K030930 | Oximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-N | Nellcor Puritan Bennett, Inc. | 2003 | — |
| 0 (this device) | K041644 | Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible)… | Elekon Industries U.S.A., Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K86378 | Nellcor, BCI, and Datex pulse oximeter sensors Number could not be read Summary page 1…at SpO2 Sensors Predicate Device: Elekon Flexi-StatTM sensors are substantially equivalent to Nellcor, BCI, and Datex pulse oximeter sensors marketed under 5 10(k) # K86378, K030930, K962156, and K983684. These sensors are also equivalent to Envitec's after-market sensors marketed under 5 10(k) # K9… | |
| * | K030930 | Oximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-NSummary page 1…Sensors Predicate Device: Elekon Flexi-StatTM sensors are substantially equivalent to Nellcor, BCI, and Datex pulse oximeter sensors marketed under 5 10(k) # K86378, K030930, K962156, and K983684. These sensors are also equivalent to Envitec's after-market sensors marketed under 5 10(k) # K992215.… | 2003 |
| * | K962156 | 3304 Pulse OximeterSummary page 1…Predicate Device: Elekon Flexi-StatTM sensors are substantially equivalent to Nellcor, BCI, and Datex pulse oximeter sensors marketed under 5 10(k) # K86378, K030930, K962156, and K983684. These sensors are also equivalent to Envitec's after-market sensors marketed under 5 10(k) # K992215. Descript… | 1996 |
| * | K983684 | Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse OximetersSummary page 1…ice: Elekon Flexi-StatTM sensors are substantially equivalent to Nellcor, BCI, and Datex pulse oximeter sensors marketed under 5 10(k) # K86378, K030930, K962156, and K983684. These sensors are also equivalent to Envitec's after-market sensors marketed under 5 10(k) # K992215. Description: The Fle… | 1998 |
| * | K992215 | Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult Disposable…Summary page 1…er sensors marketed under 5 10(k) # K86378, K030930, K962156, and K983684. These sensors are also equivalent to Envitec's after-market sensors marketed under 5 10(k) # K992215. Description: The Flexi-Stat(tm) SPO2 Sensor is an electro-optical sensor that functions without skin penetration, electri… | 2000 |
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 7 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 2 other devices also cite its predicate K030930.
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 Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041644 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041644: Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible), (Datex-Compatible).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041644
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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