510(k) · Cleared
ClearedLF Process Indicator Tape for Steam Sterilization
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intertape Polymer Group · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Feb 20, 2026 as substantially equivalent to K161024 (Canadian Technical Tape, Ltd., 2016) after a 30-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Feb 20, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
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 deviceK260181 LF Process Indicator Tape for Steam SterilizationIntertape Polymer Group · 2026
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) | K260181 | LF Process Indicator Tape for Steam Sterilization | Intertape Polymer Group | 2026 | — |
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 |
|---|---|---|---|
| * | K161024 | Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization TapeSummary page 5…I, 21 CFR § 880.2800(b) Product Code: JOJ P R E D I C A T E D EV I C E : Intertape Polymer Group Process Indicator Tape for Steam Sterilization (K161024) D EV I C E D E S C R I P T I O N : The LF Process Indicator Tape for Steam Sterilization is designed to seal packs that a… | 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 26 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K161024.
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. 2026, 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 LF Process Indicator Tape for Steam Sterilization is designed to use on disposable wraps for sealing packs that are exposed to steam sterilization. The tape distinguishes between items processed and unprocessed in both gravity discharge and pre-vacuum steam sterilization processes. It is intended for use 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…
Read the full statement (114 words)
The LF Process Indicator Tape for Steam Sterilization is designed to use on disposable wraps for sealing packs that are exposed to steam sterilization. The tape distinguishes between items processed and unprocessed in both gravity discharge and pre-vacuum steam sterilization processes. It is intended for use 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. 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 green indicator lines turn dark brown/black once exposed to the steam process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260181: LF Process Indicator Tape for Steam Sterilization.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260181
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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