Cleared Traditional

K163223 - ORCA (tm) - Operational Rescue Containment Apparatus (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163223 · Isovac Products, LLC · General Hospital
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 128d · This submission: 351d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.