510(k) · Cleared
ClearedTytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual Digital LCD Sphygmomanometer, Model A830 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tytan Medical Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jan 14, 2010 as substantially equivalent to K033025 (Tytan Medical Corp., 2003) and 1 other predicate after a 115-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Jan 14, 2010
- Review
- 115 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K871718 (1987). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK871718 Modified Model UA-711 Digital SphygmonometerA&D Engineering, Inc. · 1987
- 2 generations backK032499 A & D Medical Lifesource UA-704 Digital Blood Pressure MonitorsA&D Engineering, Inc. · 2003
- 1 generation backK061456 A & D Medical UM-101 Digital Blood Pressure MonitorA&D Engineering, Inc. · 2006
- This deviceK092893 Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual…Tytan Medical Corp. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871718 | Modified Model UA-711 Digital Sphygmonometer | A&D Engineering, Inc. | 1987 | — |
| −2 | K032499 | A & D Medical Lifesource UA-704 Digital Blood Pressure Monitors | A&D Engineering, Inc. | 2003 | — |
| −1 | K061456 | A & D Medical UM-101 Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2006 | — |
| 0 (this device) | K092893 | Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual Digital LCD… | Tytan Medical Corp. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 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 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? (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 |
|---|---|---|---|
| * | K033025 | Tytan Professional /Economy Series Sphygmomanometer, NO 710/NO 700Summary page 1…RE MEASUREMENT SYSTEM ( per 21CFR section 870.1130) Class II (performance standards) CARDIOVASCULAR DXN TYTAN Professional / Economy Series Sphygmomanometer 710, 700 (K033025); A & D Medical UM-101 Digital Blood Pressure Monitor(K061456) El = toazeas Tytan Medical Corp. Tel:886-2-2298… | 2003 |
| * | K061456 | A & D Medical UM-101 Digital Blood Pressure MonitorSummary page 1…performance standards) CARDIOVASCULAR DXN TYTAN Professional / Economy Series Sphygmomanometer 710, 700 (K033025); A & D Medical UM-101 Digital Blood Pressure Monitor(K061456) El = toazeas Tytan Medical Corp. Tel:886-2-2298-9579 E-mail:[email protected] Fax:886-2-2298-9578 Website:… | 2006 |
| † | K051539 | Tricot Blood Pressure Cuff | 2005 |
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 23 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 6 ancestors has a recall.
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. 2010, 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 TYTAN Automatic Aneroid Sphygmomanometer model A730 and TYTAN Manual Digital LCD Sphygmomanometer model A830 are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures, at hospital or professional environment by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092893: Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual Digital LCD Sphygmomanometer, Model A830 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092893
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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