510(k) · Cleared
ClearedPADnet Xpress
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collaborative Care Diagnostics, LLC, D.B.A. Biomedix · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Cleared on Oct 20, 2022 as substantially equivalent to K122281 (Biomedix, Inc., 2012) after a 238-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Oct 20, 2022
- Review
- 238 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K973644 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK973644 Flostat Vascular LabBiomedix, Inc. · 1997
- 3 generations backK042616 Biomedix Padnet LabBiomedix, Inc. · 2004
- 2 generations backK073146 Padnet+Biomedix, Inc. · 2007
- 1 generation backK122281 Padnet 2.0Biomedix, Inc. · 2012
- This deviceK220527 PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. Biomedix · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973644 | Flostat Vascular Lab | Biomedix, Inc. | 1997 | — |
| −3 | K042616 | Biomedix Padnet Lab | Biomedix, Inc. | 2004 | — |
| −2 | K073146 | Padnet+ | Biomedix, Inc. | 2007 | — |
| −1 | K122281 | Padnet 2.0 | Biomedix, Inc. | 2012 | — |
| 0 (this device) | K220527 | PADnet Xpress | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | 2022 | — |
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 JOM? 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 JOM device
- #1 K201046 Automated ankle brachial pressure index…score 1.4 · 4 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 |
|---|---|---|---|
| * | K122281 | Padnet 2.0Summary page 4…r Hydraulic 870.2780 JOM 21 CFR 807.92(a)(3) Product Code | Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) K122281 PADnet 2.0 JOM 21 CFR 807.92(a)(4) Device Description Summary PADnet Xpress, like the PADnet 2.0 aids clinicians in the diagno… | 2012 |
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 25 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All JOM devicesJOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JOM
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JOM
Too few JOM 510(k)s in any year since 2007 to give a median.
Recalls per year · JOM
No recall names JOM since 2007.
Adverse event reports per year · JOM
1in 2007
MAUDE reports naming product code JOM, 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 | 2 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PADnet Xpress is a non-invasive device used to assess the lower and upper extremity arterial circulatory systems in order to assist in the identification of vascular disease in adults. To assess the arterial system, PADnet Xpress uses pulse volume recording. It is intended to be used by healthcare professionals in either a professional medical or home environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non-intact skin.
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/K220527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220527: PADnet Xpress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220527
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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