Cleared Traditional

K073168 - AESCULAP PRIMELINE CONTAINER LTD.

K073168 is the FDA 510(k) clearance for AESCULAP PRIMELINE CONTAINER LTD. by Aesculap, Inc.. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K073168 · Aesculap, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
171d
Days
Class 2
Risk

K073168 is an FDA 510(k) clearance for the AESCULAP PRIMELINE CONTAINER LTD.. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on April 28, 2008 after a review of 171 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 Aesculap, Inc. devices

Submission Details

510(k) Number K073168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2007
Decision Date April 28, 2008
Days to Decision 171 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 129d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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 - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 161
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K073168.
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K090371 · STERIS Corporation · May 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K090562 · Smith & Nephew, Inc. · Mar 2009
INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS
K072211 · Intuitive Surgical, Inc. · Feb 2008
VIS-U-ALL II SELF SEAL POUCH
K070765 · STERIS Corporation · Oct 2007
VHP 136 TRAY
K070769 · STERIS Corporation · Oct 2007