510(k) · Cleared
ClearedVtrust Finger Type Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · DQA Oximeter
Cleared on Nov 22, 2011 as substantially equivalent to K101012 (Taidoc Technology Corporation, 2010) after a 237-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Nov 22, 2011
- Review
- 237 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K911124 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK911124 503 Pulse OximeterCriticare Systems, Inc. · 1991
- 1 generation backK101012 V-Trust Handheld Pulse Oximeter Model: TD-8201Taidoc Technology Corporation · 2010
- This deviceK110893 Vtrust Finger Type Pulse OximeterTaidoc Technology Corporation · 2011
- Descendant · cites it directly · 0 of its ownK151024 Finger Type Pulse OximeterTaidoc Technology Corporation · 2016
Most influential descendants
Showing 1 of 1 · See all- K151024Finger Type Pulse OximeterTaidoc Technology Corporation · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911124 | 503 Pulse Oximeter | Criticare Systems, Inc. | 1991 | — |
| −1 | K101012 | V-Trust Handheld Pulse Oximeter Model: TD-8201 | Taidoc Technology Corporation | 2010 | — |
| 0 (this device) | K110893 | Vtrust Finger Type Pulse Oximeter | Taidoc Technology Corporation | 2011 | — |
| +1 | K151024 | Finger Type Pulse Oximeter | Taidoc Technology Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K101012 | V-Trust Handheld Pulse Oximeter Model: TD-8201Summary page 2…stant and dust resistant level 1P56. 5. Substantial Equivalence Information: A. Predicate device name: V-TRUST Handheld Pulse Oximeter B3. Predicate K number: K(101012 C. Comparison-with predicate: The proposed device has the following similarities to the predicate device: 0… | 2010 |
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 |
|---|---|---|---|
| K151024 | Finger Type Pulse Oximeter | 2016 | 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 20 years and passes through 2 companies; a new generation was cleared every 19.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K151024 (Taidoc Technology Corporation, 2016) 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. 2011, 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 VTRUST Finger Type Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults.
This device is indicated for non-invasive spot checking.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110893: Vtrust Finger Type 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/K110893
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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