Cleared Traditional

K934688 - STERILE DESIGN

K934688 is an FDA 510(k) clearance for STERILE DESIGN, manufactured by Sterile Design, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K934688 · Sterile Design, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
167d
Days
Class 2
Risk

K934688 is an FDA 510(k) clearance for the STERILE DESIGN. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Sterile Design, Inc. (Oldsmar, US). The FDA issued a Cleared decision on March 16, 1994 after a review of 167 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sterile Design, Inc. devices

FDA 510(k) Submission Details - K934688

510(k) Number K934688 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received September 30, 1993
Decision Date March 16, 1994
Days to Decision 167 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 115d · This submission: 167d
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 67
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K934688.
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K953083 · Hospital Laundry Services · May 1996
JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY
K961683 · J.J. Skinner, Inc. · May 1996
WOUND CLOSURE/LACERATION TRAY
K950295 · Customed, Inc. · Apr 1995
INSTRUMENT TRAY
K935743 · Cush Medical Products · Mar 1994
CENTRAL LINE TRAY
K936117 · Cush Medical Products · Mar 1994
DRESSING CHANGE TRAY
K935686 · Cush Medical Products · Feb 1994