Cleared Traditional

K103200 - PROPEP DELIVERY DEVICE

K103200 is an FDA 510(k) clearance for PROPEP DELIVERY DEVICE, manufactured by Rhythmlink International, LLC. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K103200 · Rhythmlink International, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
162d
Days
Class 2
Risk

K103200 is an FDA 510(k) clearance for the PROPEP DELIVERY DEVICE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on April 12, 2011 after a review of 162 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Rhythmlink International, LLC devices

FDA 510(k) Submission Details - K103200

510(k) Number K103200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2010
Decision Date April 12, 2011
Days to Decision 162 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
33d slower than avg
Panel avg: 129d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 330
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K103200.
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EPIDRUM
K093863 · Exmoor Plastics , Ltd. · May 2010