Cleared Special

K150174 - EMMA (FDA 510(k) Clearance)

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

K150174 · Inrange Systems, Inc. · General Hospital
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Feb 2015
Decision
31d
Days
Class 2
Risk

K150174 is an FDA 510(k) clearance for the EMMA. Classified as Medication Management System, Remote (product code NZH), Class II - Special Controls.

Submitted by Inrange Systems, Inc. (Altoona, US). The FDA issued a Cleared decision on February 26, 2015 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6315 - the FDA general hospital device 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.

View all Inrange Systems, Inc. devices

Submission Details

510(k) Number K150174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2015
Decision Date February 26, 2015
Days to Decision 31 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 128d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

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.