Cleared Traditional

K052798 - CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C (FDA 510(k) Clearance)

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

K052798 · Isovac Products, LLC · General Hospital
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Jun 2006
Decision
246d
Days
Class 2
Risk

K052798 is an FDA 510(k) clearance for the CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C. Classified as Chamber, Patient Transport Isolation (product code LGN), Class II - Special Controls.

Submitted by Isovac Products, LLC (Bellaire, US). The FDA issued a Cleared decision on June 6, 2006 after a review of 246 days - an extended review cycle.

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. 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 Isovac Products, LLC devices

Submission Details

510(k) Number K052798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date June 06, 2006
Days to Decision 246 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
118d slower than avg
Panel avg: 128d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGN Chamber, Patient Transport 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.