510(k) Report

510(k) · Cleared

Cleared

Sterrad NX Challenge Pack

K042450510(k) TraditionalCleared May 12, 2005245-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

Advanced Sterilization Products · FRC Indicator, Biological Sterilization Process

Cleared on May 12, 2005 after a 245-day review. The FDA summary names its predicate without a number. 24 later devices descend from it.

Decided
May 12, 2005
Review
245 days
Class
Class II
Product code
FRC
Recalls
None
Predicates
0

24 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2014: 3 descendants cleared2009: 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 cleared20052010201520202025
  1. This deviceK042450 Sterrad NX Challenge PackAdvanced Sterilization Products · 2005
  2. Descendant · cites it directly · 23 of its ownK051643 Sterrad Sterilizer Cyclesure Test PackAdvanced Sterilization Products · 2005
  3. Descendant · 2 generations on · 21 of its ownK073618 Verify Sirius Biological Indicator Challenge PackSTERIS Corporation · 2009
  4. Descendant · 3 generations on · 20 of its ownK092906 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2009
  5. Descendant · 4 generations on · 15 of its ownK103331 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2011
  6. Descendant · 5 generations on · 14 of its ownK140499 Verify V24 Self-Contained Biological Indicator for Vaporized VH202…STERIS Corporation · 2014

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2005: 12009: 22011: 12014: 32017: 12018: 42019: 32022: 12023: 22024: 22025: 32026: 1
2005high 4 (2018) · low 0 (2006)2026

Most influential descendants

Showing 5 of 24 · See all
  • K051643Sterrad Sterilizer Cyclesure Test PackAdvanced Sterilization Products · 2005 · cites it directly23descendants
  • K073618Verify Sirius Biological Indicator Challenge PackSTERIS Corporation · 2009 · 2 generations on21descendants
  • K092906Verify Biological Indicator Challenge Pack for Vaporized VH202 SterilizationSTERIS Corporation · 2009 · 3 generations on20descendants
  • K103331Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization ProcessesSTERIS Corporation · 2011 · 4 generations on15descendants
  • K140499Verify V24 Self-Contained Biological Indicator for Vaporized VH202 Sterilization ProcessesSTERIS Corporation · 2014 · 5 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042450Sterrad NX Challenge PackAdvanced Sterilization Products2005—
+1K051643Sterrad Sterilizer Cyclesure Test PackAdvanced Sterilization Products2005—
+2K073618Verify Sirius Biological Indicator Challenge PackSTERIS Corporation2009—
+3K092906Verify Biological Indicator Challenge Pack for Vaporized VH202 SterilizationSTERIS Corporation2009—
+4K103331Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization…STERIS Corporation2011—
+5K140499Verify V24 Self-Contained Biological Indicator for Vaporized VH202…STERIS Corporation2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200920
201110
201430
201710
201840
201930
202210
202320
202420
202530
202610
FIG. 1 — Lineage of K042450, 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? (2)

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
*—STERRAD CycleSure Biological Indicator
Named without a submission number
—
*—STERRAD BI Test Pack
Named without a submission number
—

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K051643Sterrad Sterilizer Cyclesure Test PackAdvanced Sterilization Products200523

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?

  • Of its descendants, K051643 (Advanced Sterilization Products, 2005) has gone furthest, with 23 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.

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 STERRAD NX Test Pack is used for routine monitoring of the STERRAD® NX Sterilization cycle and is also used for the periodic testing of a STERRAD NX System using hospital-defined loads.

Indications for use as stated in the FDA summary.

More from Advanced Sterilization Products

54 FDA decisions under this applicant name. See the company

  • K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray…Advanced Sterilization Products · 2024
  • K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek…Advanced Sterilization Products · 2017
  • K162007STERRAD NX SterilizerAdvanced Sterilization Products · 2017
  • K160818STERRAD® NX Sterilizer with ALLClear™ TechnologyAdvanced Sterilization Products · 2016
  • K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products · 2016

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/K042450 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042450: Sterrad NX Challenge Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042450

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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