510(k) · Cleared
ClearedPadcheck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Padtest, LLC · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Apr 1, 2010 as substantially equivalent to K042616 (Biomedix, Inc., 2004) and 1 other predicate after a 170-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Apr 1, 2010
- Review
- 170 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.
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) | K093205 | Padcheck | Padtest, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 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 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 |
|---|---|---|---|
| * | K042616 | Biomedix Padnet LabSummary page 1…ulation Number: 21 CFR 870.1130 3. Identification of Legally Marketed Devices Name: PADnet Lab K Number: K042616 Name: VP-l000 K Number: K013434 4. Product Overview PADCH-EK ABIIPVR per… | 2004 |
| * | K013434 | VP-2000/1000Summary page 1…rketed Devices Name: PADnet Lab K Number: K042616 Name: VP-l000 K Number: K013434 4. Product Overview PADCH-EK ABIIPVR performs an Ankle Brachial Index (ABI) test by measuring systolic lBP at the b… | 2002 |
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 4 companies; a new generation was cleared every 7.7 years on median.
- None of the 11 ancestors has a recall.
- 2 other devices also cite its predicate K042616.
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 PADChek ABI/PVR is a non-invasive device used to a94ist in the detection of peripheral artery disease (PAD). Pressure measurements at the ankles (dorsalis pedis and/or posterior tibialis arteries) are compared to the highest pressure in either arm (brachial arteries) and a ABI (Ankle Brachial Index) is calculated. A P'ulse Volume Recording (PVR) is simultaneously performed to determine the presence of blood flow. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or .fetal use. Tt is also not intended for use on or near non intact skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093205: Padcheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093205
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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