Not Cleared Post-NSE

DEN060002 - INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN060002 · Inrange Systems, Inc. · General Hospital
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Jun 2007
Decision
265d
Days
Class 2
Risk

DEN060002 is an FDA 510(k) submission (not cleared) for the INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM. Classified as Medication Management System, Remote (product code NZH), Class II - Special Controls.

Submitted by Inrange Systems, Inc. (Altoona, US). The FDA issued a Not Cleared (DENG) decision on June 13, 2007 after a review of 265 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6315 - the FDA general hospital device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 265 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Inrange Systems, Inc. devices

Submission Details

510(k) Number DEN060002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 21, 2006
Decision Date June 13, 2007
Days to Decision 265 days
Submission Type Post-NSE
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 128d · This submission: 265d
Pathway characteristics

Device Classification

Product Code NZH Medication Management System, Remote
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6315
Definition A Remote Medication Management System Provides A Means For The Patient's Prescribed Medications To Be Stored In A Delivery Unit; For A Medical Provider To Remotely Schedule The Patient's Prescribed Medications; To Provide Notification To The Patient When The Prescribed Medications Are Due To Be Taken; To Release The Prescribed Medications To A Tray Of The Delivery Unit Accessible To The Patient On The Patient's Command; And To Provide To The Medical Provider A History Of The Event. The System Is Intended For Use As An Aid To Medical Providers In Managing Therapeutic Regimens For Patients In The Home Or Clinic.
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 General Hospital devices follow this clearance model.