Cleared Traditional

K042580 - TIDI BRAND STERILIZATION WRAP

K042580 is an FDA 510(k) clearance for TIDI BRAND STERILIZATION WRAP, manufactured by Banta Healthcare Group, Ltd.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K042580 · Banta Healthcare Group, Ltd. · General Hospital
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Nov 2004
Decision
56d
Days
Class 2
Risk

K042580 is an FDA 510(k) clearance for the TIDI BRAND STERILIZATION WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Banta Healthcare Group, Ltd. (Clearwater, US). The FDA issued a Cleared decision on November 17, 2004 after a review of 56 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 Banta Healthcare Group, Ltd. devices

FDA 510(k) Submission Details - K042580

510(k) Number K042580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2004
Decision Date November 17, 2004
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

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 - FRG Wrap, Sterilization

All 246
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K042580.
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WAGNER STERISET STERILIZATION CONTAINER
K041096 · Wagner GmbH · Jun 2005
REUSABLE STERILCONTAINER FILTER MODEL #JK090
K041623 · Aesculap, Inc. · Dec 2004
STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS
K022978 · Case Medical, Inc. · May 2003
PROTEC-TOP, STERIDENT, BENTO
K031022 · Ronpak, Inc. · Apr 2003
STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM
K023614 · Case Medical, Inc. · Apr 2003

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.