Cleared Special

K161024 - Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape

K161024 is an FDA 510(k) clearance for Canadian Technical Tape, manufactured by Canadian Technical Tape, Ltd.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Special 510(k) pathway after a 77-day FDA review.

K161024 · Canadian Technical Tape, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
77d
Days
Class 2
Risk

K161024 is an FDA 510(k) clearance for the Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Canadian Technical Tape, Ltd. (Montreal, CA). The FDA issued a Cleared decision on June 28, 2016 after a review of 77 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K161024

510(k) Number K161024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2016
Decision Date June 28, 2016
Days to Decision 77 days
Submission Type Special
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
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Highpower Validation and Testing Lab Services, Inc.
Gary Socola

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 - JOJ Indicator, Physical/chemical Sterilization Process

All 246
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