Cleared Traditional

K163223 - ORCA (tm) - Operational Rescue Containment Apparatus

K163223 is an FDA 510(k) clearance for ORCA (tm) - Operational Rescue Containm..., manufactured by Isovac Products, LLC. The device is a Class 2 General Hospital device with product code LGM cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K163223 · Isovac Products, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
351d
Days
Class 2
Risk

K163223 is an FDA 510(k) clearance for the ORCA (tm) - Operational Rescue Containment Apparatus. Classified as Chamber, Patient Isolation (product code LGM), Class II - Special Controls.

Submitted by Isovac Products, LLC (Romeoville, US). The FDA issued a Cleared decision on November 2, 2017 after a review of 351 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 Isovac Products, LLC devices

FDA 510(k) Submission Details - K163223

510(k) Number K163223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2016
Decision Date November 02, 2017
Days to Decision 351 days
Submission Type Traditional
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
222d slower than avg
Panel avg: 129d · This submission: 351d
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 Consultant

Jl Jones Group, Inc.
JEFFERY JONES

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LGM Chamber, Patient Isolation

All 9
Devices cleared under the same product code (LGM) and FDA review panel - the closest regulatory comparables to K163223.
Carecube Negative Pressure Isolation Chamber
K231256 · Carecubes, Inc. · Jan 2024
PATIENT ISOLATION UNIT, MODEL G019-1000
K080117 · Gentex Corporation · Jan 2009
FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
K022260 · Isolation Systems, Inc. · Aug 2002
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