Cleared Traditional

K882684 - REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR...

K882684 is an FDA 510(k) clearance for REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR..., manufactured by Standard Textile Co., Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K882684 · Standard Textile Co., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
34d
Days
Class 2
Risk

K882684 is an FDA 510(k) clearance for the REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS.. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on August 3, 1988 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - the FDA general and plastic surgery 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 Standard Textile Co., Inc. devices

FDA 510(k) Submission Details - K882684

510(k) Number K882684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1988
Decision Date August 03, 1988
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRO Device Classification - Class 2, Special Controls

Product Code LRO General Surgery Tray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRO General Surgery Tray

All 55
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K882684.
SUTURE REMOVAL KIT
K890729 · Cypress Medical Products, Ltd. · Apr 1989
TRACHEOSTOMY CARE AND CLEANING KITS
K890726 · Cypress Medical Products, Ltd. · Mar 1989
HOMER MAMMALOK LOCALIZATION SHIELD
K885090 · North American Instrument Corp. · Feb 1989
ALCON SURGICAL PROCEDURE PACKS
K880961 · Alcon Laboratories · Apr 1988
SOFT TISSUE ANCHORING SET KIT
K874439 · Concept, Inc. · Nov 1987
BLOOD CONTAINMENT PACK
K872448 · Professional Medical Services · Nov 1987