Cleared Traditional

K103009 - SENTICARE PILLSTATION

K103009 is an FDA 510(k) clearance for SENTICARE PILLSTATION, manufactured by Senticare, Inc.. The device is a Class 1 General Hospital device with product code NXQ cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K103009 · Senticare, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
108d
Days
Class 1
Risk

K103009 is an FDA 510(k) clearance for the SENTICARE PILLSTATION. Classified as Reminder, Medication (product code NXQ), Class I - General Controls.

Submitted by Senticare, Inc. (Washington, US). The FDA issued a Cleared decision on January 28, 2011 after a review of 108 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 890.5050 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Senticare, Inc. devices

FDA 510(k) Submission Details - K103009

510(k) Number K103009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2010
Decision Date January 28, 2011
Days to Decision 108 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 129d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

NXQ Device Classification - Class 1, General Controls

Product Code NXQ Reminder, Medication
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5050
Definition A Medication Reminder Is A Device Intended For Medical Purposes To Provide Alerts To Patients Or Healthcare Providers For Pre-determined Medication Dosing Schedules. The Device May Incorporate Wireless Communication.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.