Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PADNET 2.0

K-Number: K122281 · 2012-08-29

ApplicantBiomedix, Inc.
Decision Date2012-08-29
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PADNET 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Biomedix, Inc.. It received FDA 510(k) clearance on 2012-08-29 under 510(k) number K122281. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PADNET 2.0?

PADNET 2.0 is a medical device that received FDA 510(k) clearance on 2012-08-29. The listed applicant is Biomedix, Inc.. The 510(k) number is K122281.

When did PADNET 2.0 receive FDA 510(k) clearance?

PADNET 2.0 received FDA 510(k) clearance on 2012-08-29, under 510(k) number K122281.

Who is the listed applicant for PADNET 2.0?

The FDA 510(k) record lists Biomedix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PADNET 2.0?

The FDA product code for PADNET 2.0 is JOM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biomedix, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K073146PADNET+K050182Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEMK042616BIOMEDIX PADNET LABK033627Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEMK973857FLOSTAT VASCULAR REPORT GENERATOR (VRG)K973644FLOSTAT VASCULAR LAB

View all 10 devices →

Related Devices (Code: JOM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220527PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. BiomedixK213730MESI mTABLET TBI diagnostic system, MESI mTABLET TBIMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.K200567ASI Plethysmogrpah AnalyzerArterial Stiffness, Inc.K201046Automated ankle brachial pressure index measuring device, MESI mTABLET systemMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.K191266VitalScan ANSMedeia, Inc.K172655Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑