Cleared Traditional

K950850 - GENT-L-KARE LACERATION TRAYS

K950850 is an FDA 510(k) clearance for GENT-L-KARE LACERATION TRAYS, manufactured by Premium Plastics, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K950850 · Premium Plastics, Inc. · General Hospital
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Mar 1995
Decision
18d
Days
Class 2
Risk

K950850 is an FDA 510(k) clearance for the GENT-L-KARE LACERATION TRAYS. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Premium Plastics, Inc. (Chicago, US). The FDA issued a Cleared decision on March 14, 1995 after a review of 18 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 Premium Plastics, Inc. devices

FDA 510(k) Submission Details - K950850

510(k) Number K950850 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 24, 1995
Decision Date March 14, 1995
Days to Decision 18 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - FRG Wrap, Sterilization

All 239
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K950850.
LACERATION TRAY
K955658 · Transidyne General Corp. · Jan 1996
STERIMED STERIZATION WRAPPER (NON-STERILE)
K953678 · Customed, Inc. · Oct 1995
SAFEDWEEL DRESSING CHANGE TRAY
K950438 · Becton Dickinson Vascular Access, Inc. · Mar 1995
MAMMOCORE BIOPSY TRAY
K943653 · Manan Medical Products, Inc. · Jan 1995
BIOPSY TRAY
K941645 · Cush Medical Products · Jul 1994
ORION CENTRAL LINE DRESSING CHANGE TRAY
K941542 · Regulatory & Marketing Services, Inc. · May 1994