510(k) · Cleared
ClearedTytan Professional /Economy Series Sphygmomanometer, NO 710/NO 700
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 Dec 10, 2003 after a 75-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Dec 10, 2003
- Review
- 75 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK033025 Tytan Professional /Economy Series Sphygmomanometer, NO 710/NO 700Tytan Medical Corp. · 2003
- Descendant · cites it directly · 0 of its ownK092893 Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual…Tytan Medical Corp. · 2010
Most influential descendants
Showing 1 of 1 · See all- K092893Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual Digital LCD…Tytan Medical Corp. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033025 | Tytan Professional /Economy Series Sphygmomanometer, NO 710/NO 700 | Tytan Medical Corp. | 2003 | — |
| +1 | K092893 | Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual Digital LCD… | Tytan Medical Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092893 | Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual Digital LCD… | 2010 | 0 |
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?
- Of its descendants, K092893 (Tytan Medical Corp., 2010) has gone furthest, with 0 descendants of its own.
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.
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 device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference ranges are 3 1/2" to 5 1/4", 3 3/4" to 7 1/2", 7" to 10 3/4", 10 3/4" to 15 3/4", and 13 1/3" to 19 1/2". The patient population targets are newborn, infant, child, adult.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033025: Tytan Professional /Economy Series Sphygmomanometer, NO 710/NO 700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033025
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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