510(k) · Cleared
ClearedMediaid Pulse Oximeter M30 and M34
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediaid, Inc. · DQA Oximeter
Cleared on Nov 5, 2007 as substantially equivalent to K943842 (Palco Laboratories, Inc., 1995) and 1 other predicate after a 145-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it.
- Decided
- Nov 5, 2007
- Review
- 145 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001930 (2000). 4 ancestors in all, the oldest K943842 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001930 Model 8500, Hand Held Pulse Oximeter, Model 8500Nonin Medical, Inc. · 2000
- 1 generation backK050056 Model 2500A Palmsat Pulse OximeterNonin Medical, Inc. · 2005 · Recalled
- This deviceK071610 Mediaid Pulse Oximeter M30 and M34Mediaid, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK100225 Pulse Oximeter Model P10Mediana Co., Ltd. · 2011
- Descendant · 2 generations on · 2 of its ownK152659 V10Mediana Co., Ltd. · 2016
- Descendant · 3 generations on · 1 of its ownK170497 V10Mediana Co., Ltd. · 2017 · Recalled
- Descendant · 4 generations on · 0 of its ownK200434 V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · Recalled
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001930 | Model 8500, Hand Held Pulse Oximeter, Model 8500 | Nonin Medical, Inc. | 2000 | — |
| −1 | K050056 | Model 2500A Palmsat Pulse Oximeter | Nonin Medical, Inc. | 2005 | 1 |
| 0 (this device) | K071610 | Mediaid Pulse Oximeter M30 and M34 | Mediaid, Inc. | 2007 | — |
| +1 | K100225 | Pulse Oximeter Model P10 | Mediana Co., Ltd. | 2011 | — |
| +2 | K152659 | V10 | Mediana Co., Ltd. | 2016 | — |
| +3 | K170497 | V10 | Mediana Co., Ltd. | 2017 | 1 |
| +4 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K943842 | Pulse Oximeter Model 305Summary page 1…Class: II Predicate Device: Mediaid (formally Palco Labs) Pulse Oximeter Model 34 is substantially equivalent to Mediaid / Palco Pulse Oximeter Model 305 marketed under K943842 and Nonin Model 2500 marketed under K050056. Comparative matrices between the proposed devices and other devices are provided. Pl… | 1995 |
| * | K050056 | Model 2500A Palmsat Pulse OximeterSummary page 1…ly Palco Labs) Pulse Oximeter Model 34 is substantially equivalent to Mediaid / Palco Pulse Oximeter Model 305 marketed under K943842 and Nonin Model 2500 marketed under K050056. Comparative matrices between the proposed devices and other devices are provided. Please refer to section 12. Model 34 is ident… | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100225 | Pulse Oximeter Model P10 | 2011 | 3 |
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 2 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K100225 (Mediana Co., Ltd., 2011) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K943842.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Non-invasive measurement of arterial oxygen saturation and pulse rate in
hospitals, physician's office, emergency medical facilities, or at home. The model 34 can store
data in memory for later review and documentation and also features a sleep mode for basic
patient sleep screening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071610 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071610: Mediaid Pulse Oximeter M30 and M34.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071610
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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