510(k) · Cleared
ClearedReusable Finger Clip SPO2 Sensors
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 Nov 26, 2004 as substantially equivalent to K041647 (Elekon Industries U.S.A., Inc., 2004) after a 57-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Nov 26, 2004
- Review
- 57 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962603 (1997). 9 ancestors in all, the oldest K955642 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 3 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 2 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 1 generation backK041647 Flexi-Stat Reusable Finger Clip SPO2 Sensors…Elekon Industries U.S.A., Inc. · 2004
- This deviceK042704 Reusable Finger Clip SPO2 SensorsElekon Industries U.S.A., Inc. · 2004
- Descendant · cites it directly · 0 of its ownK061191 Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric…Measurement Specialties, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K061191Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use…Measurement Specialties, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −4 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −3 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −2 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −1 | K041647 | Flexi-Stat Reusable Finger Clip SPO2 Sensors… | Elekon Industries U.S.A., Inc. | 2004 | — |
| 0 (this device) | K042704 | Reusable Finger Clip SPO2 Sensors | Elekon Industries U.S.A., Inc. | 2004 | — |
| +1 | K061191 | Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors… | Measurement Specialties, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K041647 | Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible)…Summary page 1…Name: SpO2 Sensor (accessory to pulse oximeter) Trade Name(s): Flexi-Stat SpO2 Sensors Predicate Device: The proposed devices are identical to the devices cleared under K041647 with the exception of added pediatric claims. Description: The Flexi-Stat(tm) Sp02 Sensor is an electro-optical sensor that func… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061191 | Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use… | 2006 | 0 |
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 10 months on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K061191 (Measurement Specialties, Inc., 2006) has gone furthest, with 0 descendants of its own.
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 SpO 2 Sensor is indicated for continuous, non-invasive functional arterial
oxygen saturation and pulse rate monitoring in patients weighing >20 kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042704: Reusable Finger Clip SPO2 Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042704
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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