510(k) · Cleared
Cleared503 Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Criticare Systems, Inc. · DQA Oximeter
Cleared on Jun 7, 1991 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jun 7, 1991
- Review
- 87 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK911124 503 Pulse OximeterCriticare Systems, Inc. · 1991
- Descendant · cites it directly · 2 of its ownK101012 V-Trust Handheld Pulse Oximeter Model: TD-8201Taidoc Technology Corporation · 2010
- Descendant · 2 generations on · 1 of its ownK110893 Vtrust Finger Type Pulse OximeterTaidoc Technology Corporation · 2011
- Descendant · cites it directly · 1 of its ownK101259 V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010
- Descendant · 2 generations on · 0 of its ownK172221 VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs…Taidoc Technology Corporation · 2018
- Descendant · 3 generations on · 0 of its ownK151024 Finger Type Pulse OximeterTaidoc Technology Corporation · 2016
Most influential descendants
Showing 5 of 5 · See all- K101012V-Trust Handheld Pulse Oximeter Model: TD-8201Taidoc Technology Corporation · 2010 · cites it directly2descendants
- K110893Vtrust Finger Type Pulse OximeterTaidoc Technology Corporation · 2011 · 2 generations on1descendant
- K101259V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010 · cites it directly1descendant
- K172221VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100Taidoc Technology Corporation · 2018 · 2 generations on0descendants
- K151024Finger Type Pulse OximeterTaidoc Technology Corporation · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911124 | 503 Pulse Oximeter | Criticare Systems, Inc. | 1991 | — |
| +1 | K101012 | V-Trust Handheld Pulse Oximeter Model: TD-8201 | Taidoc Technology Corporation | 2010 | — |
| +2 | K110893 | Vtrust Finger Type Pulse Oximeter | Taidoc Technology Corporation | 2011 | — |
| +1 | K101259 | V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002 | Taidoc Technology Corporation | 2010 | — |
| +2 | K172221 | VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model… | Taidoc Technology Corporation | 2018 | — |
| +3 | K151024 | Finger Type Pulse Oximeter | Taidoc Technology Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 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?
- Of its descendants, K101012 (Taidoc Technology Corporation, 2010) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K911124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911124: 503 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/K911124
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026