Cleared Traditional

K941542 - ORION CENTRAL LINE DRESSING CHANGE TRAY

K941542 is an FDA 510(k) clearance for ORION CENTRAL LINE DRESSING CHANGE TRAY, manufactured by Regulatory & Marketing Services, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K941542 · Regulatory & Marketing Services, Inc. · General Hospital
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May 1994
Decision
54d
Days
Class 2
Risk

K941542 is an FDA 510(k) clearance for the ORION CENTRAL LINE DRESSING CHANGE TRAY. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Regulatory & Marketing Services, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on May 23, 1994 after a review of 54 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K941542

510(k) Number K941542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 30, 1994
Decision Date May 23, 1994
Days to Decision 54 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 129d · This submission: 54d
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 268
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K941542.
BIOPSY TRAY
K941645 · Cush Medical Products · Jul 1994
RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE
K931874 · Amsco Sterile Recoveries, Inc. · Jun 1994
AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE
K931875 · Amsco Sterile Recoveries, Inc. · Jun 1994
BURN DRESSING TRAY
K942000 · Medcare Custom Packaging, Inc. · May 1994
WOUND DRESSING KIT
K941467 · Clinical Resources, Inc. · May 1994
DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
K941468 · Clinical Resources, Inc. · May 1994
K941542 · ORION CENTRAL LINE DRESSING CHANGE TRAY
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