510(k) · Cleared
ClearedCanadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canadian Technical Tape, Ltd. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Jun 28, 2016 as substantially equivalent to K140940 (Canadian Technical Tape, Ltd., 2014) after a 77-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Jun 28, 2016
- Review
- 77 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001649 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001649 Steritec Autoclave Tapes, Model CI122 & CI1234Steritec Products, Inc. · 2000
- 1 generation backK140940 Process Indicator Tape for Steam SterilizationCanadian Technical Tape, Ltd. · 2014
- This deviceK161024 Canadian Technical Tape, LTd. LF Process Indicator Steam…Canadian Technical Tape, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK260181 LF Process Indicator Tape for Steam SterilizationIntertape Polymer Group · 2026
- Descendant · cites it directly · 0 of its ownK191741 Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam…Intertape Polymer, Inc. · 2019
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 |
|---|---|---|---|---|---|
| −2 | K001649 | Steritec Autoclave Tapes, Model CI122 & CI1234 | Steritec Products, Inc. | 2000 | — |
| −1 | K140940 | Process Indicator Tape for Steam Sterilization | Canadian Technical Tape, Ltd. | 2014 | — |
| 0 (this device) | K161024 | Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape | Canadian Technical Tape, Ltd. | 2016 | — |
| +1 | K260181 | LF Process Indicator Tape for Steam Sterilization | Intertape Polymer Group | 2026 | — |
| +1 | K191741 | Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization… | Intertape Polymer, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K140940 | Process Indicator Tape for Steam SterilizationSummary page 4…Class II, 21 CFR § 880.2800(b) Product Code: JOJ PREDICATE DEVICE: Canadian Technical Tape, Ltd. Process Indicator Tape for Steam Sterilization (K140940) REFERENCE 510K DEVICE: SteriTec Green Tape (K122555) DEVICE DESCRIPTION (MODEL 143 & MODEL 144): The process indicator tape… | 2014 |
| † | K122555 | Steritec Lead Free Sterilization Process Indicator Tape | 2012 |
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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 14.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K260181 (Intertape Polymer Group, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K140940.
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. 2016, 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 Canadian Technical Tape, Ltd. LF Process Indicator Steam Sterilization Tape is indicated for use in holding sterilization packs together and can be used in gravity sterilizers operating at 121°C for 30 minutes or pre-vacuum sterilizers operating at 132°C for 4 minutes and 135°C for 3 minutes. The indicator stripes turn dark brown/black when exposed to steam sterilization conditions, thus providing an indication of processed items.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161024: Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161024
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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