Cleared Traditional

K934028 - STERILE DRESSING CHANGE TRAY

K934028 is an FDA 510(k) clearance for STERILE DRESSING CHANGE TRAY, manufactured by Surgipro, Inc.. The device is a Class 2 General Hospital device with product code LRO cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K934028 · Surgipro, Inc. · General Hospital
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Feb 1994
Decision
184d
Days
Class 2
Risk

K934028 is an FDA 510(k) clearance for the STERILE DRESSING CHANGE TRAY. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Surgipro, Inc. (Palm Florida, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 184 days - an extended review 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: 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.

View all Surgipro, Inc. devices

FDA 510(k) Submission Details - K934028

510(k) Number K934028 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received August 17, 1993
Decision Date February 17, 1994
Days to Decision 184 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
55d slower than avg
Panel avg: 129d · This submission: 184d
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 Hospital 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 K934028.
DRESSING CHANGE TRAY
K935686 · Cush Medical Products · Feb 1994
IRRIGATION TRAY
K935740 · Cush Medical Products · Feb 1994
MILL-ROSE PERCUTANEOUS PROCEDURAL KIT
K935858 · Mill-Rose Laboratory · Feb 1994
O.R. BASIN SET TRAY
K935741 · Cush Medical Products · Feb 1994
E-Z PREP(R) TRAY WITH HIBICLENS(R)
K935483 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994
CARAPACE STILLWATER BOWL SET
K931820 · Carapace, Inc. · Feb 1994