510(k) · Cleared
ClearedLeadtek Fingertip Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leadtek Research, Inc. · DQA Oximeter
Cleared on Apr 27, 2020 as substantially equivalent to K112843 (Nonin Medical, Inc., 2012) after a 146-day review. Its family tree reaches back 4 generations to 2000. 4 later devices descend from it.
- Decided
- Apr 27, 2020
- Review
- 146 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001085 (2000). 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK001085 Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500Nonin Medical, Inc. · 2000
- 3 generations backK051107 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2005
- 2 generations backK053130 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2006
- 1 generation backK112843 Pulse OximeterNonin Medical, Inc. · 2012
- This deviceK193350 Leadtek Fingertip Pulse OximeterLeadtek Research, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK223399 AViTA Pulse OximeterAvita Corporation · 2024
- Descendant · cites it directly · 0 of its ownK252448 AViTA Pulse Oximeter (SP61)Avita Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK242455 AViTA Pulse Oximeter (SP62B)Avita Corporation · 2025
- Descendant · cites it directly · 0 of its ownK210032 Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse…Leadtek Research, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K223399AViTA Pulse OximeterAvita Corporation · 2024 · cites it directly1descendant
- K252448AViTA Pulse Oximeter (SP61)Avita Corporation · 2026 · cites it directly0descendants
- K242455AViTA Pulse Oximeter (SP62B)Avita Corporation · 2025 · 2 generations on0descendants
- K210032Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)Leadtek Research, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001085 | Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 | Nonin Medical, Inc. | 2000 | — |
| −3 | K051107 | Onyx II Finger Pulse Oximeter, Model 9550 | Nonin Medical, Inc. | 2005 | — |
| −2 | K053130 | Onyx II Finger Pulse Oximeter, Model 9550 | Nonin Medical, Inc. | 2006 | — |
| −1 | K112843 | Pulse Oximeter | Nonin Medical, Inc. | 2012 | — |
| 0 (this device) | K193350 | Leadtek Fingertip Pulse Oximeter | Leadtek Research, Inc. | 2020 | — |
| +1 | K223399 | AViTA Pulse Oximeter | Avita Corporation | 2024 | — |
| +1 | K252448 | AViTA Pulse Oximeter (SP61) | Avita Corporation | 2026 | — |
| +2 | K242455 | AViTA Pulse Oximeter (SP62B) | Avita Corporation | 2025 | — |
| +1 | K210032 | Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter… | Leadtek Research, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K112843 | Pulse OximeterSummary page 4…ct Code: DQA Review Panel: Anesthesiology 3. Predicate Device Proprietary Name: Onyx Vantage 9590 510(K) Number: K112843 Manufacturer: Nonin Medical Inc. 4. Intended Use The Leadtek Fingertip Pulse Oximeter are intended for measuring… | 2012 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K223399 (Avita Corporation, 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K112843.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Leadtek Fingertip Pulse Oximeter are intended for measuring functional oxygen saturation of arterial hemoglobin
(SpO2) and pulse rate for both adults and adolescent as non-invasive spot checking in home and professional caring
environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches to 0.9 inches) and for patients during no-motion condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193350 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193350: Leadtek Fingertip Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193350
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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