510(k) Report

510(k) · Cleared

Cleared

VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM

K213412510(k) TraditionalCleared Jan 21, 202294-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 Corparation · JOJ Indicator, Physical/Chemical Sterilization Process

Cleared on Jan 21, 2022 as substantially equivalent to K152630 (STERIS Corporation, 2016) and 1 other predicate after a 94-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it.

Decided
Jan 21, 2022
Review
94 days
Class
Class II
Product code
JOJ
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K012195 (2002). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2025: 1 descendant clearedK012195 · Steam Sterilization Intergrator · Dana Products, Inc. · 2002K152630 · VERIFY STEAM Integrating Indicator · STERIS Corporation · 2016 · recalledK162631 · VERIFY STEAM Integrating Indicator - Short · STERIS Corporation · 2017200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K162631 · VERIFY STEAM Integrating Indicator - Short · STERIS Corporation · 2017K152630 · VERIFY STEAM Integrating Indicator · STERIS Corporation · 2016 · recalledK012195 · Steam Sterilization Intergrator · Dana Products, Inc. · 20020
  1. Root · 3 generations backK012195 Steam Sterilization IntergratorDana Products, Inc. · 2002
  2. 2 generations backK152630 VERIFY STEAM Integrating IndicatorSTERIS Corporation · 2016 · Recalled
  3. 1 generation backK162631 VERIFY STEAM Integrating Indicator - ShortSTERIS Corporation · 2017
  4. This deviceK213412 VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating…Steris Corparation · 2022
  5. Descendant · cites it directly · 0 of its ownK243876 VERIFY STEAM Integrating IndicatorSTERIS Corporation · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K243876VERIFY STEAM Integrating IndicatorSTERIS Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K012195Steam Sterilization IntergratorDana Products, Inc.2002—
−2K152630VERIFY STEAM Integrating IndicatorSTERIS Corporation20161
−1K162631VERIFY STEAM Integrating Indicator - ShortSTERIS Corporation2017—
0 (this device)K213412VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CMSteris Corparation2022—
+1K243876VERIFY STEAM Integrating IndicatorSTERIS Corporation2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K213412, 2002–2025Source: 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 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 JOJ? 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 JOJ device

  1. #1 K261992 3M™ Attest™ Steam Chemical Integrator (1243A…score 13.3 · 5 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
*K152630VERIFY STEAM Integrating Indicator
Summary page 8
…ation process Classification Number: 21 CFR 880.2800 Product Code: JOJ 2. Predicate Device VERIFY STEAM Integrating Indicator, K152630 3. Description of Device The VERIFY STEAM Integrating Indicator is a single use device used by healthcare providers to mon…
STERIS Corporation20161
*K162631VERIFY STEAM Integrating Indicator - Short
Summary page 14
…ess Classification Number: 21 CFR 880.2800 Product Code: JOJ 2. Predicate Device VERIFY STEAM Integrating Indicator - Short, K162631 3. Description of Device The VERIFY STEAM Integrating Indicator 5CM is a single use device used by healthcare providers to…
STERIS Corporation2017—

Also cleared against K152630: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K243876VERIFY STEAM Integrating IndicatorSTERIS Corporation20250

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 20 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K243876 (STERIS Corporation, 2025) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K152630.

How does its category compare?

All JOJ devices

JOJ Indicator, Physical/Chemical Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · JOJ

6in 2025

2007: 82008: 92009: 72010: 62011: 132012: 72013: 62014: 62015: 82016: 42017: 72018: 52019: 122020: 72021: 42022: 82023: 42024: 122025: 62026 (partial year): 3
2007high 13 (2011) · low 4 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOJ

90in 2025

2007: 140 days median2008: 57 days median2009: 188 days median2010: 115 days median2011: 151 days median2012: 224 days median2013: 212 days median2014: 198 days median2015: 188 days median2016: 150 days median2017: 172 days median2018: 150 days median2019: 38 days median2020: 108 days median2021: 87 days median2022: 90 days median2023: 53 days median2024: 71 days median2025: 90 days median2026 (partial year): 30 days median
2007high 224 (2012) · low 38 (2019)2026

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

Recalls per year · JOJ

1in 2023

2008: 22009: 22011: 22021: 12023: 1
2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JOJ

12in 2025

2007: 12008: 12009: 92010: 32011: 12012: 82013: 62014: 112015: 72016: 112017: 352018: 122019: 82020: 62021: 292022: 232023: 392024: 252025: 12
2007high 39 (2023) · low 1 (2007)2025

MAUDE reports naming product code JOJ, 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
2007814001
200895721
2009718829
2010611503
20111315121
2012722408
2013621206
20146198011
2015818807
20164150011
20177172035
20185150012
2019123808
2020710806
2021487129
2022890023
2023453139
20241271025
2025690012
20263300—

What is it indicated for?

The integrating indicator is designed to chemically react over time with the critical parameters of a 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: Steam Sterilization Cycles: • 250 °F/121° C, 30 minutes Gravity • 270 °F/132…

Read the full statement (380 words)

The integrating indicator is designed to chemically react over time with the critical parameters of a 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:

Steam Sterilization Cycles:

• 250 °F/121° C, 30 minutes Gravity

• 270 °F/132 °C, 4 minutes Dynamic Air Removal

• 270 °F/132 °C, 5 minutes Dynamic Air Removal

• 270 °F/132 °C, 6 minutes Dynamic Air Removal

• 270 °F/132 °C, 7 minutes Dynamic Air Removal

• 270 °F/132 °C, 8 minutes Dynamic Air Removal

• 270 °F/132° C, 9 minutes Dynamic Air Removal

• 270 °F/132 °C, 10 minutes Dynamic Air Removal

• 270 °F/132 °C, 15 minutes Gravity

• 273 °F/134 °C, 4 minutes Dynamic Air Removal

• 275° F/135 °C, 3 minutes Dynamic Air Removal

• 275° F/135 °C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

270 °F/132 °C, 4 minutes Dynamic Air Removal

270 °F/132 °C, 3 minutes Gravity

270 °F/132 °C, 10 minutes Gravity

275 °F/135 °C, 3 minutes Dynamic Air Removal

275 °F/135 °C, 3 minutes Gravity

275° F/135 °C, 10 minutes Gravity

The integrating indicator is designed to chemically react over time with the critical parameters of a 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:

Steam Sterilization Cycles:

• 250°F/121°C, 30 minutes Gravity

• 270°F/132°C, 4 minutes Dynamic Air Removal

• 270°F/132°C, 5 minutes Dynamic Air Removal

• 270°F/132°C, 6 minutes Dynamic Air Removal

• 270°F/132°C, 7 minutes Dynamic Air Removal

• 270°F/132°C, 8 minutes Dynamic Air Removal

• 270°F/132°C, 9 minutes Dynamic Air Removal

• 270°F/132°C, 10 minutes Dynamic Air Removal

• 270°F/132°C, 15 minutes Gravity

• 273°F/134°C, 4 minutes Dynamic Air Removal

• 275°F/135°C, 3 minutes Dynamic Air removal

• 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

• 270°F/132°C, 4 minutes Dynamic Air Removal

• 270°F/132°C, 3 minutes Gravity

• 270°F/132°C, 10 minutes Gravity

• 275°F/135°C, 3 minutes Dynamic Air Removal

• 275°F/135°C, 3 minutes Gravity

• 275°F/135°C, 10 minutes Gravity

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K152630

2 other devices cite the same predicate.

  • K200252Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg Co, Inc. · 2020
  • K162631VERIFY STEAM Integrating Indicator - ShortSTERIS Corporation · 2017

More from Steris Corparation

2 FDA decisions under this applicant name. See the company

  • K250140Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation · 2025

Recent decisions in JOJ

The JOJ category page

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  • K260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer Group · 2026
  • K251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen…Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. · 2025
  • K251035DISINTEK™ PA Test StripsSerim Research · 2025

https://510kreport.com/device/K213412 · printed Nov 4, 2026

Cite this page

510(k) Report. “K213412: VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213412

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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