Cleared Special

K201337 - InPen System

K201337 is the FDA 510(k) clearance for InPen System by Companion Medical, Inc.. It is a Class 2 General Hospital device (product code NDC) cleared through the Special 510(k) pathway after a 29-day FDA review.

K201337 · Companion Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
29d
Days
Class 2
Risk

K201337 is an FDA 510(k) clearance for the InPen System. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Companion Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on June 18, 2020 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.1890 - 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 Companion Medical, Inc. devices

Submission Details

510(k) Number K201337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2020
Decision Date June 18, 2020
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NDC Calculator, Drug Dose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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.

Regulatory Peers - NDC Calculator, Drug Dose

All 24
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