Cleared Special

K073146 - PADNET+

K073146 is an FDA 510(k) clearance for PADNET+, manufactured by Biomedix, Inc.. The device is a Class 2 Cardiovascular device with product code JOM cleared through the Special 510(k) pathway after a 13-day FDA review.

K073146 · Biomedix, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
13d
Days
Class 2
Risk

K073146 is an FDA 510(k) clearance for the PADNET+. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Biomedix, Inc. (Vadnais Heights, US). The FDA issued a Cleared decision on November 21, 2007 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2780 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K073146

510(k) Number K073146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2007
Decision Date November 21, 2007
Days to Decision 13 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

JOM Device Classification - Class 2, Special Controls

Product Code JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

All 38
Devices cleared under the same product code (JOM) and FDA review panel - the closest regulatory comparables to K073146.
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