510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye

K191021510(k) TraditionalCleared Sep 13, 2019149-day reviewClass II21 CFR 880.2800Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Terragene S.A. · FRC Indicator, Biological Sterilization Process

Cleared on Sep 13, 2019 after a 149-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it. It has been recalled once.

Decided
Sep 13, 2019
Review
149 days
Class
Class II
Product code
FRC
Recalls
1
Predicates
0

9 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2021: 1 descendant cleared2022: 2 descendants cleared2025: 2 descendants cleared2024: 1 descendant cleared2023: 3 descendants cleared201620182020202220242026
  1. This deviceK191021 Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene…Terragene S.A. · 2019
  2. Descendant · cites it directly · 3 of its ownK212193 Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators…Plasmapp Co,., Ltd. · 2021
  3. Descendant · cites it directly · 0 of its ownK251991 SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014…Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. · 2025
  4. Descendant · cites it directly · 0 of its ownK242860 Type 5 Integrating Indicator for Steam (CSPN-15)True Indicating, LLC · 2025
  5. Descendant · cites it directly · 0 of its ownK242453 Terragene® Bionova® Photon Process Challenge Device with…Terragene S.A. · 2024
  6. Descendant · 2 generations on · 0 of its ownK231169 STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI…Plasmapp Co,., Ltd. · 2023

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2021: 12022: 22023: 32024: 12025: 2
2021high 3 (2023) · low 0 (2026)2026

Most influential descendants

Showing 5 of 9 · See all
  • K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD…Plasmapp Co,., Ltd. · 2021 · cites it directly3descendants
  • K251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure…Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. · 2025 · cites it directly0descendants
  • K242860Type 5 Integrating Indicator for Steam (CSPN-15)True Indicating, LLC · 2025 · cites it directly0descendants
  • K242453Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…Terragene S.A. · 2024 · cites it directly0descendants
  • K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K191021Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape…Terragene S.A.2019—
+1K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators…Plasmapp Co,., Ltd.2021—
+1K251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016)…Shenzhen Safesecure Medical Infection Control Tech Co., Ltd.2025—
+1K242860Type 5 Integrating Indicator for Steam (CSPN-15)True Indicating, LLC2025—
+1K242453Terragene® Bionova® Photon Process Challenge Device with unique-point…Terragene S.A.2024—
+2K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for…Plasmapp Co,., Ltd.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202220
202330
202410
202520
FIG. 1 — Lineage of K191021, 2019–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FRC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FRC device

  1. #1 K250044 Celerity 5 HP Biological Indicator (LCB052)…score 14.5 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (9)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD…Plasmapp Co,., Ltd.20213
K251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure…Shenzhen Safesecure Medical Infection Control Tech Co., Ltd.20250
K242860Type 5 Integrating Indicator for Steam (CSPN-15)True Indicating, LLC20250
K242453Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…Terragene S.A.20240
K222137OK Plus IndicatorPropper Manufacturing Co., Inc.20220
K212592Gas-Chex IndicatorPropper Manufacturing Co., Inc.20220

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 7, 2023Class IIZ-0836-2024Labeling False and MisleadingDue to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K212193 (Plasmapp Co,., Ltd., 2021) has gone furthest, with 3 descendants of its own.

How does its category compare?

All FRC devices

FRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · FRC

6in 2025

2007: 32008: 12009: 62010: 42011: 62012: 92013: 42014: 132015: 32016: 22017: 102018: 182019: 52020: 102021: 52022: 52023: 62024: 82025: 62026 (partial year): 1
2007high 18 (2018) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRC

29in 2025

2007: 83 days median2009: 183 days median2010: 165 days median2011: 118 days median2012: 178 days median2013: 260 days median2014: 174 days median2015: 130 days median2017: 130 days median2018: 97 days median2019: 88 days median2020: 150 days median2021: 107 days median2022: 193 days median2023: 190 days median2024: 105 days median2025: 29 days median
2007high 260 (2013) · low 29 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRC

8so far in 2026, the most since 2007

2009: 12012: 22013: 22022: 42023: 12026 (partial year): 8
2007high 8 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FRC

9in 2025

2007: 1002008: 602009: 452010: 572011: 372012: 462013: 392014: 512015: 1822016: 4822017: 1822018: 222019: 302020: 162021: 102022: 92023: 202024: 222025: 9
2007high 482 (2016) · low 9 (2022)2025

MAUDE reports naming product code FRC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073830100
20081—060
20096183145
20104165057
20116118037
20129178246
20134260239
201413174051
201531300182
20162—0482
2017101300182
20181897022
2019588030
202010150016
20215107010
2022519349
20236190120
20248105022
202562909
20261—8—

What is it indicated for?

Terragene Bionova® SCBI (BT224) is a self-contained biological indicator inoculated with viable 10⁶ Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization processes. On each Terragene Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam. Terragene Bionova® PCD (PCD224-C, PCD224-2) and Integron® PCD (PCD26-C, PCD26-2) provides a defined…

Read the full statement (679 words)

Terragene Bionova® SCBI (BT224) is a self-contained biological indicator inoculated with viable 10⁶ Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization processes. On each Terragene Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam.

Terragene Bionova® PCD (PCD224-C, PCD224-2) and Integron® PCD (PCD26-C, PCD26-2) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification testing steam sterilization processes.

Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60° C and 37° C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.

Terragene Bionova® SCBI (BT110) is a self-contained biological indicator inoculated with viable 10⁶ Bacillus atrophaeus bacterial spores and is intended for monitoring the efficacy of ethylene oxide sterilization processes.

The integrator Terragene Integron® IT12 is designed to chemically react over time with the critical parameters of ethylene oxide sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: 55°C for 240 minutes, 600 mg/l, RH 60 %. SV37°C/75 min., SV54°C/30 min, SV55ºC/28 min.

Terragene Chemdye® CD16 is a chemical process indicator intended for monitoring the efficacy of ethylene oxide sterilization processes. The chemical indicator changes from purple/brown to green to indicate that the conditions of the cycle have been met.

Terragene Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with viable 10⁶ Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT95 is Rapid Readout while BT96 is Super Rapid Readout. BT95 has Rapid readout at 2 hours at 60° C while BT96 has Super Rapid readout at 30 minutes at 60° C.

Terragene Chemdye® (CD40, CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from purple to green for CD40 and red to yellow for CD42 to indicate that the conditions of the cycle have been met.

The integrator Terragene Integron® IT26-1YS is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min.

The integrator Terragene Integron® IT26-C is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min..

Terragene Chemdye® CD29 is a chemical process indicator intended for monitoring the efficacy of steam sterilization processes. The chemical indicator changes from yellow to dark brown/black to indicate that the conditions of the cycle have been met.

Terragene Cintape® CT22 is a chemical process indicator tape intended for monitoring the efficacy of steam sterilization processes. The indicating tape changes from yellow to dark brown/black when exposure to steam.

Terragene Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K191021: Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191021

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026