510(k) · Cleared
ClearedMediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediaid, Inc. · DQA Oximeter
Cleared on May 2, 2008 as substantially equivalent to K943842 (Palco Laboratories, Inc., 1995) and 4 other predicates after a 319-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- May 2, 2008
- Review
- 319 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K910772 (1991). 29 ancestors in all, the oldest K893221 (1990). No later device cites it as a predicate yet.
- Root · 7 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 6 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 2 generations backK031487 Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc. · 2004
- 1 generation backK053209 Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement…Suntech Medical, Inc. · 2006
- This deviceK071642 Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series…Mediaid, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −6 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −2 | K031487 | Model Avant 2120 Pulse Oximeter and Nibp | Nonin Medical, Inc. | 2004 | — |
| −1 | K053209 | Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System | Suntech Medical, Inc. | 2006 | — |
| 0 (this device) | K071642 | Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse Oximeter | Mediaid, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (5)
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 2…5. Substantial Equivalence: The Mediaid Pulse Oximeter Model 900 is substantially equivalent to the following devices: * Model 305 of Mediaid Palco marketed under K943842 · Model 340 of Mediaid Palco marketed under K920066 * Model 120 of Mediaid Palco marketed under K994372 The Mediaid Vital… | 1995 |
| * | K920066 | Palco Labs Model 340 Pulse OximeterSummary page 2…ter Model 900 is substantially equivalent to the following devices: * Model 305 of Mediaid Palco marketed under K943842 · Model 340 of Mediaid Palco marketed under K920066 * Model 120 of Mediaid Palco marketed under K994372 The Mediaid Vital Signs Monitor Model 960 series is substantially equival… | 1993 |
| * | K994372 | MODEL 120Summary page 2…ing devices: * Model 305 of Mediaid Palco marketed under K943842 · Model 340 of Mediaid Palco marketed under K920066 * Model 120 of Mediaid Palco marketed under K994372 The Mediaid Vital Signs Monitor Model 960 series is substantially equivalent to the following devices: For Pulse Oximeter ·… | 2000 |
| * | K040490 | Welch Allyn Spot Ultra Vital Signs DeviceSummary page 2…of Mediaid Palco marketed under K920066 * Model 120 of Mediaid Palco marketed under K994372 For Ni-BP Monitor: * Welch Allyn Spot Ultra Vital Signs marked under K040490 : Tango+Automatic Blood pressure and Oxygen Saturation Measurement System of Suntech Medical Inc Marketed under K05320… | 2004 |
| * | K053209 | Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement SystemSummary page 2…yn Spot Ultra Vital Signs marked under K040490 : Tango+Automatic Blood pressure and Oxygen Saturation Measurement System of Suntech Medical Inc Marketed under K053209. For Clinical Thermometer: * Welch Allyn Spot Ultra Vital Signs marked under K040490 Intended Use: Indications for Use T… | 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 17 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 29 ancestors have a recall of any class.
- 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. 2008, 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 Model 960 Series is a desktop monitor intended for use as a continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, non invasive blood pressure and temperature. The intended patient population comprises adult, and pediatric weighing more than 5Kg. The intended environment of use is hospital environment. Hospital use typically covers areas such as general care floors, operating rooms, special…
Read the full statement (125 words)
The Model 960 Series is a desktop monitor intended for use as a continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, non invasive blood pressure and temperature. The intended patient population comprises adult, and pediatric weighing more than 5Kg. The intended environment of use is hospital environment. Hospital use typically covers areas such as general care floors, operating rooms, special procedure areas, intensive and critical care areas within the hospital plus hospital-type facilities such as surgical centers, sub-acute centers, special nursing facilities and sleep labs. The Model 900 is an Pulse Oximeter only.
WARNING: The Model 900 and 960 Series is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071642 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071642: Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071642
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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