Cleared Traditional

K052798 - CAPSULS

K052798 is an FDA 510(k) clearance for CAPSULS, manufactured by Isovac Products, LLC. The device is a Class 2 General Hospital device with product code LGN cleared through the Traditional 510(k) pathway after a 246-day FDA review.

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

FDA 510(k) Submission Details - K052798

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
117d slower than avg
Panel avg: 129d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGN Device Classification - Class 2, Special Controls

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.