510(k) · Cleared
ClearedBiomedix Padnet Lab
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 Oct 12, 2004 as substantially equivalent to K973644 (Biomedix, Inc., 1997) after a 19-day review. Its family tree reaches back 1 generation to 1997. 5 later devices descend from it.
- Decided
- Oct 12, 2004
- Review
- 19 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973644 (1997). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK973644 Flostat Vascular LabBiomedix, Inc. · 1997
- This deviceK042616 Biomedix Padnet LabBiomedix, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK073146 Padnet+Biomedix, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK122281 Padnet 2.0Biomedix, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK220527 PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. Biomedix · 2022
- Descendant · cites it directly · 0 of its ownK103693 Vantage AbiSummit Doppler Systems, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK093205 PadcheckPadtest, LLC · 2010
Most influential descendants
Showing 5 of 5 · See all- K073146Padnet+Biomedix, Inc. · 2007 · cites it directly2descendants
- K122281Padnet 2.0Biomedix, Inc. · 2012 · 2 generations on1descendant
- K220527PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. Biomedix · 2022 · 3 generations on0descendants
- K103693Vantage AbiSummit Doppler Systems, Inc. · 2011 · cites it directly0descendants
- K093205PadcheckPadtest, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973644 | Flostat Vascular Lab | Biomedix, Inc. | 1997 | — |
| 0 (this device) | K042616 | Biomedix Padnet Lab | Biomedix, Inc. | 2004 | — |
| +1 | K073146 | Padnet+ | Biomedix, Inc. | 2007 | — |
| +2 | K122281 | Padnet 2.0 | Biomedix, Inc. | 2012 | — |
| +3 | K220527 | PADnet Xpress | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | 2022 | — |
| +1 | K103693 | Vantage Abi | Summit Doppler Systems, Inc. | 2011 | — |
| +1 | K093205 | Padcheck | Padtest, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K973644 | Flostat Vascular LabSummary page 2…tion Numb er: 870.2780 Identification of Legally Marketed Devices Name: Flostat Vascular Lab K Number: K973644 Date Cleared: December 23, 1997 Description of the Device The BioMedix PADnet Lab is a non invasive cardio… | 1997 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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 Lab is a non invasive device used to record physiological data from the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures for use by the Physician in the identification of vascular pathology. 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 use on or near non intact skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042616: Biomedix Padnet Lab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042616
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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