510(k) · Cleared
ClearedPadnet 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedix, Inc. · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Cleared on Aug 29, 2012 as substantially equivalent to K073146 (Biomedix, Inc., 2007) after a 30-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Aug 29, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K973644 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK973644 Flostat Vascular LabBiomedix, Inc. · 1997
- 2 generations backK042616 Biomedix Padnet LabBiomedix, Inc. · 2004
- 1 generation backK073146 Padnet+Biomedix, Inc. · 2007
- This deviceK122281 Padnet 2.0Biomedix, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK220527 PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. Biomedix · 2022
Most influential descendants
Showing 1 of 1 · See all- K220527PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. Biomedix · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973644 | Flostat Vascular Lab | Biomedix, Inc. | 1997 | — |
| −2 | K042616 | Biomedix Padnet Lab | Biomedix, Inc. | 2004 | — |
| −1 | K073146 | Padnet+ | Biomedix, Inc. | 2007 | — |
| 0 (this device) | K122281 | Padnet 2.0 | Biomedix, Inc. | 2012 | — |
| +1 | K220527 | PADnet Xpress | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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 K220527 PADnet Xpressscore 5.1 · 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 |
|---|---|---|---|
| * | K073146 | Padnet+Summary page 1…I 510(k) Date Predicate I IICleared PADnet-- BioMedix Plethysmograph K073146 11/21/2007 Device Description: The primary goal of the PADnet 2.0 system is to assess the blood vascular system and assis… | 2007 |
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 |
|---|---|---|---|
| K220527 | PADnet Xpress | 2022 | 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?
- The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K220527 (Collaborative Care Diagnostics, LLC, D.B.A. Biomedix, 2022) has gone furthest, with 0 descendants of its own.
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. 2012, 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 BioMedix PADnet 2.0 is a non-invasive device used to assess the lower and upper extremity arterial and venous circulatory systems in order to assist in the identification of vascular disease. To assess the arterial system, PADnet 2.0 uses pulse volume recording, arterial pulse contour analysis, and segmental systolic & diastolic blood pressure measurements. To assess the venous valvular system, PADnet 2.0 measures venous refilling time. For…
Read the full statement (122 words)
The BioMedix PADnet 2.0 is a non-invasive device used to assess the lower and upper extremity arterial and venous circulatory systems in order to assist in the identification of vascular disease. To assess the arterial system, PADnet 2.0 uses pulse volume recording, arterial pulse contour analysis, and segmental systolic & diastolic blood pressure measurements. To assess the venous valvular system, PADnet 2.0 measures venous refilling time. For identification of venous obstruction in the deep venous (below knee) system, PADnet 2.0 measures venous outflow rate. 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. It is also not intended for the use on or near non-intact skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122281: Padnet 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122281
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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