510(k) · Cleared
ClearedFukuda Denshi Vasera Model VS-1500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fukuda Denshi USA, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Dec 21, 2011 as substantially equivalent to K013434 (Colin Corp., 2002) and 1 other predicate after a 112-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Dec 21, 2011
- Review
- 112 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K872291 (1987). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK872291 Escort Portable Patient MonitorMedical Data Electronics · 1987
- 2 generations backK973637 Press-Mate AdvantageColin Medical Instruments Corp. · 1998
- 1 generation backK013434 VP-2000/1000Colin Corp. · 2002
- This deviceK112521 Fukuda Denshi Vasera Model VS-1500Fukuda Denshi USA, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872291 | Escort Portable Patient Monitor | Medical Data Electronics | 1987 | — |
| −2 | K973637 | Press-Mate Advantage | Colin Medical Instruments Corp. | 1998 | — |
| −1 | K013434 | VP-2000/1000 | Colin Corp. | 2002 | — |
| 0 (this device) | K112521 | Fukuda Denshi Vasera Model VS-1500 | Fukuda Denshi USA, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K013434 | VP-2000/1000Summary page 3…tes that this device is as safe and effective and performs as well as the legally marketed predicate devices, the Colin Medical VP-1000/2000 (K013434) and the Fukuda Denshi DS-5300 Patient Monitor (K9641 87). Fukuda Denshi VaSera Model VS-1 500AU 510OK Submissi… | 2002 |
| * | K964187 | Fukada Denshi Dynascope Model DS-5300 Patient MonitorSummary page 2…5 10(k) Summary Legally Marketed Predicate Devices: Colin Medical VP- 1000/2000 (KO 13434) Fukuda Denshi DS-5300 Patient Monitor (K964187) Description: The Fukuda Denshi VaSera model VS-l 500AU is a prescriptive device intended for use by health care profess… | 1997 |
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 9.5 years on median.
- None of the 11 ancestors has a recall.
- 6 other devices also cite its predicate K013434.
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. 2011, 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 Fukuda Denshi VaSera model VS-1500AU is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. It has a capability of measuring non-invasive blood pressures, heart rate, pulse volume recordings and heart sounds. The device also has the capability of calculating ANI (Ankle Brachial Index), TBI (Toe Brachial Index), and pulse wave velocity measurements. The device is intended to be used under the order of…
Read the full statement (107 words)
The Fukuda Denshi VaSera model VS-1500AU is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. It has a capability of measuring non-invasive blood pressures, heart rate, pulse volume recordings and heart sounds.
The device also has the capability of calculating ANI (Ankle Brachial Index), TBI (Toe Brachial Index), and pulse wave velocity measurements.
The device is intended to be used under the order of a physician, in hospitals, doctor's offices, clinics or other medical facilities where non-invasive peripheral vascular tests are performed.
The device is intended to be used on adult population only.
The device is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112521: Fukuda Denshi Vasera Model VS-1500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112521
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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