510(k) · Cleared
ClearedMiroxi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mir Medical Intl. Research Srl · DQA Oximeter
Cleared on Jan 15, 2009 as substantially equivalent to K061712 (Mir Medical Intl. Research Srl, 2006) after a 279-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Jan 15, 2009
- Review
- 279 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943404 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK943404 3301 Pulse OximeterBci Intl., Inc. · 1994
- 3 generations backK013171 3420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002
- 2 generations backK043528 SpirotelMir Medical Intl. Research Srl · 2005
- 1 generation backK061712 Spirobank IIMir Medical Intl. Research Srl · 2006
- This deviceK081033 MiroxiMir Medical Intl. Research Srl · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943404 | 3301 Pulse Oximeter | Bci Intl., Inc. | 1994 | — |
| −3 | K013171 | 3420 Digit Pulse Oximeter, Model 3420 | Bci, Inc. | 2002 | — |
| −2 | K043528 | Spirotel | Mir Medical Intl. Research Srl | 2005 | — |
| −1 | K061712 | Spirobank II | Mir Medical Intl. Research Srl | 2006 | — |
| 0 (this device) | K081033 | Miroxi | Mir Medical Intl. Research Srl | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K061712 | Spirobank IISummary page 1…dentification of legally marketed device to which the submitter claims equivalence: Company Name: MIR Device Name: Spirobank HI 510(k) number: K061712 4. Description of the device: MIROxi is a pulse oximeter, designed for use by specialist who require a simple, portable and comp… | 2006 |
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 15 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 9 ancestors has a recall.
- 2 other devices also cite its predicate K061712.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 MIROxi pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic.
The device is intended to test oximetry in people of all ages.
It can be used in any setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081033: Miroxi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081033
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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