Cleared Traditional

K242453 - Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) (FDA 510(k) Clearance)

Also includes:

Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242453 · Terragene S.A. · General Hospital

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Dec 2024

Decision

115d

Days

Class 2

Risk

K242453 is an FDA 510(k) clearance for the Terragene® Bionova® Photon Process Challenge Device with unique-point integra.... Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Terragene S.A. (Alvear, AR). The FDA issued a Cleared decision on December 12, 2024 after a review of 115 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Terragene S.A. devices

Submission Details

510(k) Number	K242453 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 19, 2024
Decision Date	December 12, 2024
Days to Decision	115 days
Submission Type	Traditional
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

13d faster than avg

Panel avg: 128d · This submission: 115d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	FRC Indicator, Biological 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.