Cleared Traditional

K013709 - HILL-ROM PRIMAVIEW MONITOR SYSTEM (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013709 · Hill-Rom, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
8d
Days
Class 2
Risk

K013709 is an FDA 510(k) clearance for the HILL-ROM PRIMAVIEW MONITOR SYSTEM. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on November 16, 2001 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hill-Rom, Inc. devices

Submission Details

510(k) Number K013709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2001
Decision Date November 16, 2001
Days to Decision 8 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 130d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 97
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K013709.
ProVee Video Processing Unit (PV-003)
K251734 · Proverum Limited · Sep 2025
UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
K250462 · Univlabs Technologies Private Limited · Aug 2025
Endoscopic Camera System
K250204 · Shenzhen Sophway Technology Co., Ltd. · Jul 2025
FUJIFILM Processor EP-8000
K243260 · Fujifilm Corporation · Apr 2025
VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700
K242067 · Olympus Corporations of the Americas · Apr 2025
Endoscopic Video Image Processor (RP-IPD-V1000F)
K243321 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Feb 2025