Cleared Traditional

K080117 - PATIENT ISOLATION UNIT, MODEL G019-1000

K080117 is an FDA 510(k) clearance for PATIENT ISOLATION UNIT, manufactured by Gentex Corporation. The device is a Class 2 General Hospital device with product code LGM cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K080117 · Gentex Corporation · General Hospital
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Jan 2009
Decision
379d
Days
Class 2
Risk

K080117 is an FDA 510(k) clearance for the PATIENT ISOLATION UNIT, MODEL G019-1000. Classified as Chamber, Patient Isolation (product code LGM), Class II - Special Controls.

Submitted by Gentex Corporation (Rancho Cucamonga, US). The FDA issued a Cleared decision on January 30, 2009 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5450 - 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. Elevated predicate reliance profile. 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 Gentex Corporation devices

FDA 510(k) Submission Details - K080117

510(k) Number K080117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2008
Decision Date January 30, 2009
Days to Decision 379 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
250d slower than avg
Panel avg: 129d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGM Device Classification - Class 2, Special Controls

Product Code LGM Chamber, Patient Isolation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5450
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 - LGM Chamber, Patient Isolation

All 8
Devices cleared under the same product code (LGM) and FDA review panel - the closest regulatory comparables to K080117.
Carecube Negative Pressure Isolation Chamber
K231256 · Carecubes, Inc. · Jan 2024
ORCA (tm) - Operational Rescue Containment Apparatus
K163223 · Isovac Products, LLC · Nov 2017
MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
K912444 · Radiometer America, Inc. · Feb 1992
MODEL 7-AT TREATMENT CHAMBER
K896721 · J. H. Emerson Co. · Jan 1990
INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE
K874306 · Busse Hospital Disposables, Inc. · Mar 1988
ANAGO ISOLATION MASK (#80-950)
K864116 · Anago, Inc. · Nov 1986