510(k) · Cleared
ClearedSeca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seca GmbH & Co. KG · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jan 23, 2020 as substantially equivalent to K160439 (Suntech Medical, 2016) after a 171-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Jan 23, 2020
- Review
- 171 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K951193 (1996). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK951193 Clinical Vital Signs Monitor, Model #52STP-E1Tycos Instruments, Inc. · 1996
- 4 generations backK024005 Welch Allyn Vital Sign Monitor with MP506Welch Allyn, Inc. · 2003
- 3 generations backK040490 Welch Allyn Spot Ultra Vital Signs DeviceWelch Allyn, Inc. · 2004
- 2 generations backK101680 Welch Allyn Spot Vital Signs Lxi Model 45000 SeriesWelch Allyn, Inc. · 2010 · Recalled
- 1 generation backK160439 SunTech CT40 Spot-check Vital Signs DeviceSuntech Medical · 2016
- This deviceK192092 Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA…Seca GmbH & Co. KG · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951193 | Clinical Vital Signs Monitor, Model #52STP-E1 | Tycos Instruments, Inc. | 1996 | — |
| −4 | K024005 | Welch Allyn Vital Sign Monitor with MP506 | Welch Allyn, Inc. | 2003 | — |
| −3 | K040490 | Welch Allyn Spot Ultra Vital Signs Device | Welch Allyn, Inc. | 2004 | — |
| −2 | K101680 | Welch Allyn Spot Vital Signs Lxi Model 45000 Series | Welch Allyn, Inc. | 2010 | 2 |
| −1 | K160439 | SunTech CT40 Spot-check Vital Signs Device | Suntech Medical | 2016 | — |
| 0 (this device) | K192092 | Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 | Seca GmbH & Co. KG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2007 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K160439 | SunTech CT40 Spot-check Vital Signs DeviceSummary page 5…5. Legally Marketed Predicate Device SunTech CT40 Spot-check Vital Signs Device (Model 260), (Trade names CT40, Model 260, CT40 Spot-check Vital Signs Device), K160439, manufactured by SunTech Medical, NC, USA. The predicate device has not been subject to a design related recall. 6. Indicati… | 2016 |
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 24 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The medical Vital Signs Analyzer seca mVSA 535 is a Spot-Check device used for non-invasive, discontinuous measurement and display of NIBP (blood pressure), SpO2 (oxygen saturation of arterial hemoglobin), TEMP (body temperature) and PR (pulse rate). The vital signs monitor model seca mVSA 535 is mainly used in inpatient facilities (hospitals, medical practices and care facilities) in accordance with national regulations and is intended to be used on…
Read the full statement (125 words)
The medical Vital Signs Analyzer seca mVSA 535 is a Spot-Check device used for non-invasive, discontinuous measurement and display of NIBP (blood pressure), SpO2 (oxygen saturation of arterial hemoglobin), TEMP (body temperature) and PR (pulse rate).
The vital signs monitor model seca mVSA 535 is mainly used in inpatient facilities (hospitals, medical practices and care facilities) in accordance with national regulations and is intended to be used on adult and pediatric individuals (3 years of age or older).
The seca mVSA 535 can be used in conjunction with an optional PC software accessory for data management, calculations and display of information.
If used in conjunction with seca medical weight and height measurement devices the seca mVSA 535 can receive and display weight and height values.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192092: Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192092
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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