510(k) · Cleared
ClearedPadnet+
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 Nov 21, 2007 as substantially equivalent to K973644 (Biomedix, Inc., 1997) and 1 other predicate after a 13-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Nov 21, 2007
- Review
- 13 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973644 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK973644 Flostat Vascular LabBiomedix, Inc. · 1997
- 1 generation backK042616 Biomedix Padnet LabBiomedix, Inc. · 2004
- This deviceK073146 Padnet+Biomedix, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK122281 Padnet 2.0Biomedix, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK220527 PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. Biomedix · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973644 | Flostat Vascular Lab | Biomedix, Inc. | 1997 | — |
| −1 | K042616 | Biomedix Padnet Lab | Biomedix, Inc. | 2004 | — |
| 0 (this device) | K073146 | Padnet+ | Biomedix, Inc. | 2007 | — |
| +1 | K122281 | Padnet 2.0 | Biomedix, Inc. | 2012 | — |
| +2 | K220527 | PADnet Xpress | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K973644 | Flostat Vascular LabSummary page 2…, K733'- Identification of Legally Marketed Devices Name: Flostat Vascular Lab PADnet Lab K Number: K973644 K042616 Date Cleared: December 23, 1997 October 12, 2004 Desc… | 1997 |
| * | K042616 | Biomedix Padnet LabSummary page 2…gally Marketed Devices Name: Flostat Vascular Lab PADnet Lab K Number: K973644 K042616 Date Cleared: December 23, 1997 October 12, 2004 Description of the Device The BioMedix P… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122281 | Padnet 2.0 | 2012 | 1 |
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 10 years and passes through 1 company; a new generation was cleared every 6.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K122281 (Biomedix, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K973644.
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. 2007, 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+ is a non invasive device used to gage the lower extremity arterial and venous system, using pulse volume recording, oscillometric segmental systolic blood pressure and photo plethysmograph, to assist in the identification of vascular disease. 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/K073146 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073146: Padnet+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073146
Report an extraction error
Are you the manufacturer?
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