510(k) Report

510(k) · Cleared

Cleared

Verify Self-Contained Biological Indicator for Vaporized (VH2O2) Sterilization Processes

K090514510(k) SpecialCleared Mar 16, 200918-day reviewClass II21 CFR 880.2800

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

STERIS Corporation · FRC Indicator, Biological Sterilization Process

Cleared on Mar 16, 2009 as substantially equivalent to K073244 (STERIS Corporation, 2008) and 3 other predicates after an 18-day review. Its family tree reaches back 4 generations to 2002. 4 later devices descend from it.

Decided
Mar 16, 2009
Review
18 days
Class
Class II
Product code
FRC
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K994055 (2002). 4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2014: 2 descendants cleared2017: 1 descendant cleared2021: 1 descendant clearedK994055 · Sterrad Cyclesure Biological Indicator · Advanced Sterilization Products · 2002 · recalledK031226 · Sterrad Cyclesure Biological Indicator · Advanced Sterilization Products · 2003 · recalledK071014 · Modification to Sterrad Cyclesure Biological Indicator · Advanced Sterilization Products · 2007K073244 · Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization Processes · STERIS Corporation · 2008200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants K073244 · Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization Processes · STERIS Corporation · 2008K071014 · Modification to Sterrad Cyclesure Biological Indicator · Advanced Sterilization Products · 2007K031226 · Sterrad Cyclesure Biological Indicator · Advanced Sterilization Products · 2003 · recalledK994055 · Sterrad Cyclesure Biological Indicator · Advanced Sterilization Products · 2002 · recalled0
  1. Root · 4 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
  2. 3 generations backK031226 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2003 · Recalled
  3. 2 generations backK071014 Modification to Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2007
  4. 1 generation backK073244 Verify Self-Contained Biological Indicator for VH202 Gaseous…STERIS Corporation · 2008
  5. This deviceK090514 Verify Self-Contained Biological Indicator for Vaporized (VH2O2)…STERIS Corporation · 2009
  6. Descendant · cites it directly · 1 of its ownK141580 Sterizone Self-Contained Biological IndicatorTso3, Inc. · 2014
  7. Descendant · cites it directly · 1 of its ownK140708 Verify V24 Self-Contained Biological IndicatorSTERIS Corporation · 2014
  8. Descendant · 2 generations on · 0 of its ownK203560 STERIZONE VP4 Test PackTso3 Inc., Now A Part of Stryker · 2021
  9. Descendant · 2 generations on · 0 of its ownK172474 Celerity 20 HP Biological IndicatorSTERIS Corporation · 2017

Most influential descendants

Showing 4 of 4 · See all
  • K141580Sterizone Self-Contained Biological IndicatorTso3, Inc. · 2014 · cites it directly1descendant
  • K140708Verify V24 Self-Contained Biological IndicatorSTERIS Corporation · 2014 · cites it directly1descendant
  • K203560STERIZONE VP4 Test PackTso3 Inc., Now A Part of Stryker · 2021 · 2 generations on0descendants
  • K172474Celerity 20 HP Biological IndicatorSTERIS Corporation · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K994055Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products20021
−3K031226Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products20031
−2K071014Modification to Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products2007—
−1K073244Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization…STERIS Corporation2008—
0 (this device)K090514Verify Self-Contained Biological Indicator for Vaporized (VH2O2) Sterilization…STERIS Corporation2009—
+1K141580Sterizone Self-Contained Biological IndicatorTso3, Inc.2014—
+1K140708Verify V24 Self-Contained Biological IndicatorSTERIS Corporation2014—
+2K203560STERIZONE VP4 Test PackTso3 Inc., Now A Part of Stryker2021—
+2K172474Celerity 20 HP Biological IndicatorSTERIS Corporation2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201710
202110
FIG. 1 — Lineage of K090514, 2002–2021Source: 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 summary (predicates and 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? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K073244Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization Processes
Summary page 1
…(21 CFR 880.2800, FRC). 2. Predicate Device · Verify® Self-Contained Biological Indicator for Vaporized H202 Sterilization Processes, K073244, May 28, 2008 · STERRAD® Cyclesure TM Biological Indicator, K994055, Feb 13, 2002 · STERRAD® Cyclesure Biol…
STERIS Corporation2008—
*K994055Sterrad Cyclesure Biological Indicator
Summary page 1
…lf-Contained Biological Indicator for Vaporized H202 Sterilization Processes, K073244, May 28, 2008 · STERRAD® Cyclesure TM Biological Indicator, K994055, Feb 13, 2002 · STERRAD® Cyclesure Biological Indicator, K031226, May 2, 2003 · STERRAD® Cyclesure Biologic…
Advanced Sterilization Products20021
*K031226Sterrad Cyclesure Biological Indicator
Summary page 1
…ion Processes, K073244, May 28, 2008 · STERRAD® Cyclesure TM Biological Indicator, K994055, Feb 13, 2002 · STERRAD® Cyclesure Biological Indicator, K031226, May 2, 2003 · STERRAD® Cyclesure Biological Indicator, K071014 May 24, 2007 3. Description of Device The Ve…
Advanced Sterilization Products20031
*K071014Modification to Sterrad Cyclesure Biological Indicator
Summary page 1
…logical Indicator, K994055, Feb 13, 2002 · STERRAD® Cyclesure Biological Indicator, K031226, May 2, 2003 · STERRAD® Cyclesure Biological Indicator, K071014 May 24, 2007 3. Description of Device The Verify V24 Self-Contained Biological Indicator (SCBI) is used by healthcare…
Advanced Sterilization Products2007—

Also cleared against K073244: 2 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K141580Sterizone Self-Contained Biological IndicatorTso3, Inc.20141
K140708Verify V24 Self-Contained Biological IndicatorSTERIS Corporation20141

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K141580 (Tso3, Inc., 2014) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K073244.

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. 2009, 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?

The Verify- V24 Self-Contained Biological Indicator is intended as a standard method for

frequent monitoring of the Amsco® V-PROTM 1 Low Temperature Sterilization System.

Indications for use as stated in the FDA summary.

Also cleared against K073244

2 other devices cite the same predicate.

  • K140499Verify V24 Self-Contained Biological Indicator for Vaporized VH202 Sterilization ProcessesSTERIS Corporation · 2014
  • K140708Verify V24 Self-Contained Biological IndicatorSTERIS Corporation · 2014

More from STERIS Corporation

205 FDA decisions under this applicant name. See the company

  • K261055AMSCO 700 Steam SterilizerSTERIS Corporation · 2026
  • K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant…STERIS Corporation · 2026
  • K260766Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation · 2026
  • K252680Celerity™ 20 HP Biological IndicatorSTERIS Corporation · 2025
  • K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation · 2025

Recent decisions in FRC

The FRC category page

  • K260766Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation · 2026
  • K252680Celerity™ 20 HP Biological IndicatorSTERIS Corporation · 2025
  • K251122Terragene® Bionova® BT20 Biological IndicatorTerragene · 2025
  • K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP…Steris · 2025
  • K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP…STERIS Corporation · 2025

https://510kreport.com/device/K090514 · printed Nov 5, 2026

Cite this page

510(k) Report. “K090514: Verify Self-Contained Biological Indicator for Vaporized (VH2O2) Sterilization Processes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090514

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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