510(k) · Cleared
ClearedGetinge Assured MI Steam Migrating Integrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steritec Products Mfg Co, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on May 21, 2020 as substantially equivalent to K152630 (STERIS Corporation, 2016) after a 108-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- May 21, 2020
- Review
- 108 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K012195 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK012195 Steam Sterilization IntergratorDana Products, Inc. · 2002
- 1 generation backK152630 VERIFY STEAM Integrating IndicatorSTERIS Corporation · 2016 · Recalled
- This deviceK200252 Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg Co, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK242795 Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg. (A Getinge Group Company) · 2024
Most influential descendants
Showing 1 of 1 · See all- K242795Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg. (A Getinge Group Company) · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012195 | Steam Sterilization Intergrator | Dana Products, Inc. | 2002 | — |
| −1 | K152630 | VERIFY STEAM Integrating Indicator | STERIS Corporation | 2016 | 1 |
| 0 (this device) | K200252 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg Co, Inc. | 2020 | — |
| +1 | K242795 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg. (A Getinge Group Company) | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
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 K261992 3M™ Attest™ Steam Chemical Integrator (1243A…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152630 | VERIFY STEAM Integrating IndicatorSummary page 5…ndicator, physical/chemical sterilization process (21 CFR 880.2800, JOJ) 2. Predicate Device Steris Steam Integrating Indicator (K152630). Steris Corporation 3. Description of Device The Getinge Assured MI Steam Migrating Integrator is a single use device to… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242795 | Getinge Assured MI Steam Migrating Integrator | 2024 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 14.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K242795 (Steritec Products Mfg. (A Getinge Group Company), 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K152630.
How does its category compare?
All JOJ devicesJOJ Indicator, Physical/Chemical Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · JOJ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOJ
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOJ
12in 2025
MAUDE reports naming product code JOJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 140 | 0 | 1 |
| 2008 | 9 | 57 | 2 | 1 |
| 2009 | 7 | 188 | 2 | 9 |
| 2010 | 6 | 115 | 0 | 3 |
| 2011 | 13 | 151 | 2 | 1 |
| 2012 | 7 | 224 | 0 | 8 |
| 2013 | 6 | 212 | 0 | 6 |
| 2014 | 6 | 198 | 0 | 11 |
| 2015 | 8 | 188 | 0 | 7 |
| 2016 | 4 | 150 | 0 | 11 |
| 2017 | 7 | 172 | 0 | 35 |
| 2018 | 5 | 150 | 0 | 12 |
| 2019 | 12 | 38 | 0 | 8 |
| 2020 | 7 | 108 | 0 | 6 |
| 2021 | 4 | 87 | 1 | 29 |
| 2022 | 8 | 90 | 0 | 23 |
| 2023 | 4 | 53 | 1 | 39 |
| 2024 | 12 | 71 | 0 | 25 |
| 2025 | 6 | 90 | 0 | 12 |
| 2026 | 3 | 30 | 0 | — |
What is it indicated for?
The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray or container to function as an independent monitor of critical parameters for the following sterilization cycles: Steam Sterilization Cycles: 250°F/121°C, 30 minutes Gravity…
Read the full statement (142 words)
The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray or container 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
Stated values (as determined in a steam resistometer):
30 minutes at 121°C
9.1 minutes at 128°C
3.3 minutes at 132°C
1.5 minutes at 135°C
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200252 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200252: Getinge Assured MI Steam Migrating Integrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200252
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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