510(k) · Cleared
ClearedIntertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intertape Polymer, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Aug 2, 2019 as substantially equivalent to K140940 (Canadian Technical Tape, Ltd., 2014) and 1 other predicate after a 32-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Aug 2, 2019
- Review
- 32 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001649 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK001649 Steritec Autoclave Tapes, Model CI122 & CI1234Steritec Products, Inc. · 2000
- 2 generations backK140940 Process Indicator Tape for Steam SterilizationCanadian Technical Tape, Ltd. · 2014
- 1 generation backK161024 Canadian Technical Tape, LTd. LF Process Indicator Steam…Canadian Technical Tape, Ltd. · 2016
- This deviceK191741 Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam…Intertape Polymer, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001649 | Steritec Autoclave Tapes, Model CI122 & CI1234 | Steritec Products, Inc. | 2000 | — |
| −2 | K140940 | Process Indicator Tape for Steam Sterilization | Canadian Technical Tape, Ltd. | 2014 | — |
| −1 | K161024 | Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape | Canadian Technical Tape, Ltd. | 2016 | — |
| 0 (this device) | K191741 | Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization… | Intertape Polymer, Inc. | 2019 | — |
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 |
|---|---|---|---|
| * | K140940 | Process Indicator Tape for Steam SterilizationSummary page 4…Class II, 21 CFR § 880.2800(b) Product Code: JOJ PREDICATE DEVICE: Cantech, Intertape Polymer Inc., Ltd. Process Indicator Tape for Steam Sterilization (K140940 and K161024) (Formerly Canadian Technical Tape) DEVICE DESCRIPTION (MODEL 146 & MODEL 147): The process indicator tape disting… | 2014 |
| * | K161024 | Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization TapeSummary page 4…CFR § 880.2800(b) Product Code: JOJ PREDICATE DEVICE: Cantech, Intertape Polymer Inc., Ltd. Process Indicator Tape for Steam Sterilization (K140940 and K161024) (Formerly Canadian Technical Tape) DEVICE DESCRIPTION (MODEL 146 & MODEL 147): The process indicator tape distinguishes betwee… | 2016 |
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 19 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 3 ancestors has a recall.
- 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. 2019, 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 Bismuth 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; 132 °C for 3 minutes; 132 °C for 10 minutes; 132 °C for 15 minutes; 135 °C for 3 minutes and 135 °C for 10 minutes or pre-vacuum sterilizers operating at 132°C for 3 minutes; 132 °C for 4 minutes; 134 °C for 3 minutes; 134 °C for 4 minutes and 135°C for 3 minutes. The indicator lines turn dark brown/black when exposed to steam sterilization conditions, thus providing an indication of processed items.
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/K191741 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191741: Intertape Polymer Inc., Type 1 Bismuth 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/K191741
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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