510(k) · Cleared
ClearedSafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Dec 23, 2025 as substantially equivalent to K220564 (3M Company, 2022) and 1 other predicate after a 179-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Dec 23, 2025
- Review
- 179 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K932129 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK932129 3M Autoclave Tapes3M Company · 1994
- 2 generations backK101528 3M Comply Lead Free Process Indicators for Steam3M Company · 2010 · Recalled
- 1 generation backK220564 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free…3M Company · 2022
- This deviceK251991 SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014…Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932129 | 3M Autoclave Tapes | 3M Company | 1994 | — |
| −2 | K101528 | 3M Comply Lead Free Process Indicators for Steam | 3M Company | 2010 | 1 |
| −1 | K220564 | 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam… | 3M Company | 2022 | — |
| 0 (this device) | K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016)… | Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220564 | 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape…Summary page 6…Device Class: 2 Classification Panel: General Hospital 4.0 Predicate Device ► Steam: 3M™ Comply™ 1322 Indicator Tape (K220564) ► VHP: Terragene® Chemdye® CD42 (K.191021) 5.0 Device Description 5.1 SafeSecure Steam Sterilization Process… | 2022 |
| * | K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene…Summary page 13…Predicate Device Comparison islO(k) Number K251991 K191021 SafeSecure Vaporized Hydrogen Terragene® Chemdye® CD42 Process Product name… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
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. 2025, 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 SafeSecure Steam Sterilization Process Indicators are chemical process indicators intended for use by healthcare professionals to accompany individual units (e.g., wrapped packs) and to demonstrate that the unit has been exposed to a steam sterilization process. The indicator changes color to signal exposure to sterilization conditions. The indicators are validated for use in the following saturated steam sterilization cycles: Sterilization Type…
Read the full statement (290 words)
The SafeSecure Steam Sterilization Process Indicators are chemical process indicators intended for use by healthcare professionals to accompany individual units (e.g., wrapped packs) and to demonstrate that the unit has been exposed to a steam sterilization process.
The indicator changes color to signal exposure to sterilization conditions.
The indicators are validated for use in the following saturated steam sterilization cycles:
Sterilization Type Temperature Time
Gravity 250 °F/121°C 30 minutes
Gravity 270 °F/132°C 3, 4, 10, 15, 25 minutes
Gravity 275 °F/135°C 3, 10 minutes
Dynamic air-removal 250 °F/121°C 15, 20, 30 minutes
Dynamic air-removal 270 °F/132°C 3, 3.5, 4, 5.5, 6, 9, 10, 15 minutes
Dynamic air-removal 273 °F/134°C 3, 3.5, 4 minutes
Dynamic air-removal 275 °F/135°C 4, 10 minutes
The product includes both label and tape indicator. The labels can be printed or written on prior to application. The tapes are designed to adhere to common sterilization wraps, including untreated woven, non-woven, paper, and paper/ plastic wraps.
The SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicators are chemical process indicators intended to accompany individual packages and visually confirm that the pack has been exposed to a validated Vaporized Hydrogen Peroxide sterilization cycle.
The indicator changes color to signal exposure to sterilization conditions.
The indicators are validated for use in the following Vaporized Hydrogen Peroxide sterilization systems:
● Standard Cycle of STERRAD® 100S
● Standard cycle and Advanced cycle of STERRAD® NX
● Standard cycle, Flex cycle and Express cycle of STERRAD® 100NX
● Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX
The product includes both label and card indicator. The labels can be printed or written on prior to application. The card is designed to be placed inside the sterilization package, next to the items being sterilized.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251991: SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251991
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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