510(k) · Cleared
ClearedCross-Checks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steritec Products Mfg Co, Inc. · LRT Indicator, Sterilization
Cleared on Aug 19, 1996 after a 528-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Aug 19, 1996
- Review
- 528 days
- Class
- Class II
- Product code
- LRT
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK951113 Cross-ChecksSteritec Products Mfg Co, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK143117 Wire Sterilization Package with IndicatorsAmerican Orthodontics · 2015
- Descendant · cites it directly · 0 of its ownK132291 Namsa Chemical ProcessNorth American Science Assoc., Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951113 | Cross-Checks | Steritec Products Mfg Co, Inc. | 1996 | — |
| +1 | K143117 | Wire Sterilization Package with Indicators | American Orthodontics | 2015 | — |
| +1 | K132291 | Namsa Chemical Process | North American Science Assoc., Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 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 LRT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | ATI Division of PyMah Corporation Sterilometer Steam Strip chemical indicator strip for… Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K143117 (American Orthodontics, 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LRT devicesLRT Indicator, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRT
FDA has decided no LRT device since 2007.
Median 510(k) review, days · LRT
Too few LRT 510(k)s in any year since 2007 to give a median.
Recalls per year · LRT
No recall names LRT since 2007.
Adverse event reports per year · LRT
4in 2025
MAUDE reports naming product code LRT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SteriTec CROSS-CHECKS sterilization chemical monitoring strips are designed to be utilized in steam sterilizers operating at 132°C to 133°C (270°F to 276°F). When used as directed, the SteriTec Cross-Checks indicator strips give visible indication that sterilizing conditions were met. During steam sterilization, the check mark at the end of the strip changes from white to black, becoming as dark or darker in intensity than the black reference arrow printed on the strip.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K951113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951113: Cross-Checks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951113
Report an extraction error
Are you the manufacturer?
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