Cleared Traditional

K042062 - PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE

K042062 is an FDA 510(k) clearance for PERIPHERAL VASCULAR SHEATH TUNNELER STE..., manufactured by Bard Peripheral Vascular, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K042062 · Bard Peripheral Vascular, Inc. · General Hospital
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Sep 2004
Decision
59d
Days
Class 2
Risk

K042062 is an FDA 510(k) clearance for the PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on September 30, 2004 after a review of 59 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.

View all Bard Peripheral Vascular, Inc. devices

FDA 510(k) Submission Details - K042062

510(k) Number K042062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2004
Decision Date September 30, 2004
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 129d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KCT Device Classification - Class 2, Special Controls

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 Consultant

Kema Quality B.V.
J.A. VAN VUGT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 230
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K042062.
WINNER SELF SEAL STERILIZATION POUCH
K051242 · Winner Medical (Usa), Inc. · Dec 2005
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS
K051157 · Micromedics, Inc. · Sep 2005
MILTEX RIGID STERILIZATION CONTAINER SYSTEM
K050570 · Miltex, Inc. · Jul 2005
OLYMPUS STERILIZATION TRAYS
K033222 · Olympus Winter & Ibe GmbH · Aug 2004
MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH
K993764 · Medipack Medical Packaging Mfg. Co. · Dec 1999
CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS
K972719 · Medicel, S.A. DE C.V. · Feb 1999

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.