Cleared Traditional

K102864 - 84E SERIES SINGLE PLY WRAPPER

K102864 is an FDA 510(k) clearance for 84E SERIES SINGLE PLY WRAPPER, manufactured by Lac Mac, Ltd.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K102864 · Lac Mac, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
106d
Days
Class 2
Risk

K102864 is an FDA 510(k) clearance for the 84E SERIES SINGLE PLY WRAPPER. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Lac Mac, Ltd. (Austin, US). The FDA issued a Cleared decision on January 14, 2011 after a review of 106 days - within the typical 510(k) review window.

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: 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 - K102864

510(k) Number K102864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2010
Decision Date January 14, 2011
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
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 269
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K102864.
SIGMA STERILIZATION POUCH & ROLL
K102158 · Sigma Medical Supplies Corp. · Aug 2011
STERI-DENT, STERI-SURE
K110867 · Cpac, Inc. · Jul 2011
TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
K103210 · Advanced Sterilization Products · Jun 2011
HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS
K102783 · Hinson and Hale Medical Technologies, Inc. · Dec 2010
AESCULAP STERILCONTAINER S
K093493 · Aesculap, Inc. · Jul 2010
AESCULAP STERILCONTAINER S
K093649 · Aesculap · May 2010
K102864 · 84E SERIES SINGLE PLY WRAPPER
Download PDF FDA Summary Lac Mac, Ltd.