Cleared Traditional

K920052 - HEALTH PAK TRAY SOX BARRIERS

K920052 is an FDA 510(k) clearance for HEALTH PAK TRAY SOX BARRIERS, manufactured by Healthpak, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K920052 · Healthpak, Inc. · General Hospital
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Apr 1992
Decision
88d
Days
Class 2
Risk

K920052 is an FDA 510(k) clearance for the HEALTH PAK TRAY SOX BARRIERS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Healthpak, Inc. (Chicago, US). The FDA issued a Cleared decision on April 3, 1992 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Healthpak, Inc. devices

FDA 510(k) Submission Details - K920052

510(k) Number K920052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1992
Decision Date April 03, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 - KKX Drape, Surgical

All 193
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K920052.
QUALTEX TUBE/CORD ORGANIZER
K921350 · Deroyal Industries, Inc. · Aug 1992
BARRIER DRAPE SHEET WITH SYMETRY FABRIC
K920995 · Johnson & Johnson Medical, Inc. · May 1992
MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP
K920517 · Trinity Laboratories, Inc. · May 1992
QUALTEX SURGICAL DRAPE, MODIFICATION
K913486 · Deroyal Industries, Inc. · Feb 1992
ARTHROSCOPY CAMERA DRAPE
K915214 · O.R. Concepts, Inc. · Jan 1992
QUALTEX MAGNETIC INSTRUMENT DRAPE
K914369 · Deroyal Industries, Inc. · Dec 1991