Cleared Traditional

K934031 - STERILE CENTRAL LINE DRESSING TRAY

K934031 is an FDA 510(k) clearance for STERILE CENTRAL LINE DRESSING TRAY, manufactured by Surgipro, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K934031 · Surgipro, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
196d
Days
Class 2
Risk

K934031 is an FDA 510(k) clearance for the STERILE CENTRAL LINE DRESSING TRAY. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Surgipro, Inc. (Palm Florida, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 196 days - an extended review 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: 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 - K934031

510(k) Number K934031 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received August 17, 1993
Decision Date March 01, 1994
Days to Decision 196 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
67d slower than avg
Panel avg: 129d · This submission: 196d
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 K934031.
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
ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
K935238 · Sherwood Medical Co. · Feb 1994
INCISION/DRAINAGE TRAY
K935681 · Cush Medical Products · Feb 1994
LACERATION TRAY
K935682 · Cush Medical Products · Feb 1994