510(k) Report

510(k) · Cleared

Recalled · Class III · 2022

VERIFY STEAM Integrating Indicator

K152630510(k) TraditionalCleared May 12, 2016240-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

STERIS Corporation · JOJ Indicator, Physical/Chemical Sterilization Process

Cleared on May 12, 2016 as substantially equivalent to K012195 (Dana Products, Inc., 2002) after a 240-day review. Its family tree reaches back 1 generation to 2002. 5 later devices descend from it. It has been recalled once.

Decided
May 12, 2016
Review
240 days
Class
Class II
Product code
JOJ
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K012195 (2002). 5 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant clearedK012195 · Steam Sterilization Intergrator · Dana Products, Inc. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants K012195 · Steam Sterilization Intergrator · Dana Products, Inc. · 20020
  1. Root · 1 generation backK012195 Steam Sterilization IntergratorDana Products, Inc. · 2002
  2. This deviceK152630 VERIFY STEAM Integrating IndicatorSTERIS Corporation · 2016
  3. Descendant · cites it directly · 2 of its ownK162631 VERIFY STEAM Integrating Indicator - ShortSTERIS Corporation · 2017
  4. Descendant · cites it directly · 1 of its ownK213412 VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating…Steris Corparation · 2022
  5. Descendant · cites it directly · 1 of its ownK200252 Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg Co, Inc. · 2020
  6. Descendant · 2 generations on · 0 of its ownK243876 VERIFY STEAM Integrating IndicatorSTERIS Corporation · 2025
  7. Descendant · 2 generations on · 0 of its ownK242795 Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg. (A Getinge Group Company) · 2024

Most influential descendants

Showing 5 of 5 · See all
  • K162631VERIFY STEAM Integrating Indicator - ShortSTERIS Corporation · 2017 · cites it directly2descendants
  • K213412VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CMSteris Corparation · 2022 · cites it directly1descendant
  • K200252Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg Co, Inc. · 2020 · cites it directly1descendant
  • K243876VERIFY STEAM Integrating IndicatorSTERIS Corporation · 2025 · 2 generations on0descendants
  • K242795Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg. (A Getinge Group Company) · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K012195Steam Sterilization IntergratorDana Products, Inc.2002—
0 (this device)K152630VERIFY STEAM Integrating IndicatorSTERIS Corporation2016—
+1K162631VERIFY STEAM Integrating Indicator - ShortSTERIS Corporation2017—
+1K213412VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CMSteris Corparation2022—
+1K200252Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg Co, Inc.2020—
+2K243876VERIFY STEAM Integrating IndicatorSTERIS Corporation2025—
+2K242795Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg. (A Getinge Group Company)2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202010
202210
202410
202510
FIG. 1 — Lineage of K152630, 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? (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
*K012195Steam Sterilization Intergrator
Summary page 6
…sterilization process (21 CFR 880.2800, JOJ) 2. Predicate Device Dana Steam Sterilization Integrator (K012195), Dana Products Inc. 3. Description of Device The VERIFY® STEAM Integrating Indicator is a single use device…
Dana Products, Inc.2002—

Also cleared against K012195: 2 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K162631VERIFY STEAM Integrating Indicator - ShortSTERIS Corporation20172
K213412VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CMSteris Corparation20221
K200252Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg Co, Inc.20201

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

Recalls of this device

DateClassRecallRoot causeReason
May 25, 2022Class IIIZ-1793-2022Environmental controlFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K162631 (STERIS Corporation, 2017) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K012195.

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. 2016, 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 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…

Read the full statement (125 words)

The integrating indicator 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:

Steam Sterilization Cycles:

• 250°F/121°C, 30 minutes Gravity

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

• 270°F/132°C, 15 minutes Gravity

• 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 as stated in the FDA summary.

Also cleared against K012195

2 other devices cite the same predicate.

  • K083643Verify 275F Gravity IndicatorsSTERIS Corporation · 2009
  • K071895Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007

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 JOJ

The JOJ category page

  • K263267Endox Test StripsIbt Scientific · 2026
  • K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC · 2026
  • 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/K152630 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152630: VERIFY STEAM Integrating Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152630

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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