Cleared Traditional

Terragene? Bionova? Self-Contained Biological Indicator (BT95), Terragene? Bionova? Self-Contained Biological Indicator (BT96), Terragene? Chemdye? Chemical Process Indicator (CD42), Terragene? Cintape? Chemical Process Indicator Tape (CT40)

K231383 · Terragene S.A. · General Hospital
Sep 2024
Decision
495d
Days
Class 2
Risk

About This 510(k) Submission

K231383 is an FDA 510(k) clearance for the Terragene? Bionova? Self-Contained Biological Indicator (BT95), Terragene? Bionova? Self-Contained Biological Indicator (BT96), Terragene? Chemdye? Chemical Process Indicator (CD42), Terragene? Cintape? Chemical Process Indicator Tape (CT40), a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC), submitted by Terragene S.A. (Alvear, AR). The FDA issued a Cleared decision on September 18, 2024, 495 days after receiving the submission on May 12, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K231383 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2023
Decision Date September 18, 2024
Days to Decision 495 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FRC — Indicator, Biological Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800

Similar Devices — FRC Indicator, Biological Sterilization Process

All 204
Celerity? 20 HP Biological Indicator
K252680 · STERIS Corporation · Sep 2025
Terragene? Bionova? BT20 Biological Indicator
K251122 · Terragene · Aug 2025
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
K251452 · Steris · Jun 2025
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
K250044 · STERIS Corporation · Feb 2025
Celerity Incubator
K250061 · STERIS Corporation · Feb 2025
3M? Attest? Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M? Attest? Auto-reader 490; 3M? Attest? Auto-reader 490H; 3M? Attest? Mini Auto-reader 490M
K243501 · 3M Company · Jan 2025

More from Terragene S.A.

View all
Terragene? Bionova? Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene? Bionova? Photon Process Challenge Device with moving-front integrator (PCD225-C)
K242453 · FRC · Dec 2024
Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
DEN220042 · QVB · Jul 2024
Terragene? Chemdye? Multivariable Chemical Indicator (CD40), Terragene? Chemdye? Chemical Process Indicator (CD42), Terragene? Cintape? Chemical Process Indicator Tape (CT40)
K232103 · QKM · Apr 2024
Terragene? Bionova? Hyper Biological Indicator (BT98), Terragene? Bionova? Hyper Auto-reader Incubator (BHY), Terragene? Bionova? NanoBio Auto-reader Incubator (BNB)
K221641 · FRC · Feb 2023
Terragene Chemdye
K200272 · JOJ · Jun 2020