Cleared Traditional

K052797 - LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM

K052797 is an FDA 510(k) clearance for LAPEVAC, manufactured by Medtek Devices, Inc.. The device is a Class 2 General Hospital device with product code FYD cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K052797 · Medtek Devices, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
133d
Days
Class 2
Risk

K052797 is an FDA 510(k) clearance for the LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Medtek Devices, Inc. (Buffalo, US). The FDA issued a Cleared decision on February 13, 2006 after a review of 133 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5070 - 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.

FDA 510(k) Submission Details - K052797

510(k) Number K052797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date February 13, 2006
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYD Device Classification - Class 2, Special Controls

Product Code FYD Apparatus, Exhaust, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5070
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 - FYD Apparatus, Exhaust, Surgical

All 63
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K052797.
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K043494 · Mastel Precision Surgical Instruments, Inc. · Oct 2005
LAFACI
K032400 · Vision Pro, LLC · May 2004
SMOKE EVACUATION HOSES/TUBING
K020510 · Dm Medical, Inc. · May 2002
K052797 · LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM
Download PDF FDA Summary Medtek Devices, Inc.