510(k) Report

510(k) · Cleared

Cleared

Verify Sirius Biological Indicator Challenge Pack

K073618510(k) TraditionalCleared Jan 7, 2009378-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 Jan 7, 2009 as substantially equivalent to K051643 (Advanced Sterilization Products, 2005) after a 378-day review. Its family tree reaches back 2 generations to 2005. 21 later devices descend from it.

Decided
Jan 7, 2009
Review
378 days
Class
Class II
Product code
FRC
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K042450 (2005). 21 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2014: 2 descendants cleared2011: 1 descendant cleared2019: 3 descendants cleared2018: 4 descendants cleared2017: 1 descendant cleared2024: 2 descendants cleared2023: 2 descendants cleared2022: 1 descendant cleared2025: 3 descendants cleared2026: 1 descendant clearedK042450 · Sterrad NX Challenge Pack · Advanced Sterilization Products · 2005K051643 · Sterrad Sterilizer Cyclesure Test Pack · Advanced Sterilization Products · 200520052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 4 descendants5 generations forward: 6 descendants6 generations forward: 4 descendants7 generations forward: 2 descendants K051643 · Sterrad Sterilizer Cyclesure Test Pack · Advanced Sterilization Products · 2005K042450 · Sterrad NX Challenge Pack · Advanced Sterilization Products · 20050+5
  1. Root · 2 generations backK042450 Sterrad NX Challenge PackAdvanced Sterilization Products · 2005
  2. 1 generation backK051643 Sterrad Sterilizer Cyclesure Test PackAdvanced Sterilization Products · 2005
  3. This deviceK073618 Verify Sirius Biological Indicator Challenge PackSTERIS Corporation · 2009
  4. Descendant · cites it directly · 20 of its ownK092906 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2009
  5. Descendant · 2 generations on · 15 of its ownK103331 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2011
  6. Descendant · 3 generations on · 14 of its ownK140499 Verify V24 Self-Contained Biological Indicator for Vaporized VH202…STERIS Corporation · 2014
  7. Descendant · 4 generations on · 9 of its ownK171504 VERIFY Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017 · Recalled
  8. Descendant · 4 generations on · 8 of its ownK173488 CELERITY 20 HP Challenge PackSTERIS Corporation · 2018

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12014: 22017: 12018: 42019: 32022: 12023: 22024: 22025: 32026: 1
2009high 4 (2018) · low 0 (2010)2026

Most influential descendants

Showing 5 of 21 · See all
  • K092906Verify Biological Indicator Challenge Pack for Vaporized VH202 SterilizationSTERIS Corporation · 2009 · cites it directly20descendants
  • K103331Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization ProcessesSTERIS Corporation · 2011 · 2 generations on15descendants
  • K140499Verify V24 Self-Contained Biological Indicator for Vaporized VH202 Sterilization ProcessesSTERIS Corporation · 2014 · 3 generations on14descendants
  • K171504VERIFY Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017 · 4 generations on9descendants
  • K173488CELERITY 20 HP Challenge PackSTERIS Corporation · 2018 · 4 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K042450Sterrad NX Challenge PackAdvanced Sterilization Products2005—
−1K051643Sterrad Sterilizer Cyclesure Test PackAdvanced Sterilization Products2005—
0 (this device)K073618Verify Sirius Biological Indicator Challenge PackSTERIS Corporation2009—
+1K092906Verify Biological Indicator Challenge Pack for Vaporized VH202 SterilizationSTERIS Corporation2009—
+2K103331Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization…STERIS Corporation2011—
+3K140499Verify V24 Self-Contained Biological Indicator for Vaporized VH202…STERIS Corporation2014—
+4K171504VERIFY Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation20171
+4K173488CELERITY 20 HP Challenge PackSTERIS Corporation2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201420
201710
201840
201930
202210
202320
202420
202530
202610
FIG. 1 — Lineage of K073618, 2005–2026Source: 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? (1)

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
*K051643Sterrad Sterilizer Cyclesure Test Pack
Summary page 2
…ological Sterilization Process (21 CFR 880.2800, FRC). 2. Predicate Device STERRAD®0 Sterilizer CycleSure®a Test Pack, K051643, August 19, 2005. 3. Description of Device The Verify® Biological Indicator Challenge Pack for Vaporized VH20 S…
Advanced Sterilization Products2005—

Also cleared against K051643: 1 other device →

What descends from it? (21)

See all 21

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092906Verify Biological Indicator Challenge Pack for Vaporized VH202 SterilizationSTERIS Corporation200920

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 4 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K092906 (STERIS Corporation, 2009) has gone furthest, with 20 descendants of its own.
  • 1 other device also cites its predicate K051643.

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 Biological Indicator Challenge Pack for Vaporized H2O2 Sterilization Processes is intended for qualification testing of the Amsco V-PRO 1 Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty V-PRO 1 Sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine monitoring of the V-PRO 1 Sterilizer. It has been tested and validated solely for use in periodic testing of the V-PRO 1 Sterilizer.

Indications for use as stated in the FDA summary.

Also cleared against K051643

1 other device cites the same predicate.

  • K130263Sterrad 50/100S/200 Test PackAdvanced Sterilization Products · 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/K073618 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073618: Verify Sirius Biological Indicator Challenge Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073618

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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