Cleared Traditional

K101580 - NEV'S INK AUTOCLAVE TAPES

K101580 is an FDA 510(k) clearance for NEV'S INK AUTOCLAVE TAPES, manufactured by Nev'S Ink, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K101580 · Nev'S Ink, Inc. · General Hospital
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Jul 2010
Decision
24d
Days
Class 2
Risk

K101580 is an FDA 510(k) clearance for the NEV'S INK AUTOCLAVE TAPES. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Nev'S Ink, Inc. (Waukesha, US). The FDA issued a Cleared decision on July 1, 2010 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - 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 Nev'S Ink, Inc. devices

FDA 510(k) Submission Details - K101580

510(k) Number K101580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2010
Decision Date July 01, 2010
Days to Decision 24 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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 - JOJ Indicator, Physical/chemical Sterilization Process

All 202
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