Cleared Special

LF Process Indicator Tape for Steam Sterilization

K260181 · Intertape Polymer Group · General Hospital

Feb 2026

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K260181 is an FDA 510(k) clearance for the LF Process Indicator Tape for Steam Sterilization, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Intertape Polymer Group (Sarasota, US). The FDA issued a Cleared decision on February 20, 2026, 30 days after receiving the submission on January 21, 2026. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number	K260181 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 21, 2026
Decision Date	February 20, 2026
Days to Decision	30 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF