510(k) · Cleared
ClearedProcess Indicator Tape for Steam Sterilization
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 Oct 27, 2014 as substantially equivalent to K001649 (Steritec Products, Inc., 2000) after a 196-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Oct 27, 2014
- Review
- 196 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001649 (2000). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK001649 Steritec Autoclave Tapes, Model CI122 & CI1234Steritec Products, Inc. · 2000
- This deviceK140940 Process Indicator Tape for Steam SterilizationCanadian Technical Tape, Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK161024 Canadian Technical Tape, LTd. LF Process Indicator Steam…Canadian Technical Tape, Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK210553 Steam-Dot Process IndicatorPropper Manufacturing Co., Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK260181 LF Process Indicator Tape for Steam SterilizationIntertape Polymer Group · 2026
- Descendant · 2 generations on · 0 of its ownK241036 Autoclave Indicator Tape; EO Indicator TapeJiangmen New Era External Use Drug Co., Ltd. · 2024
- 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 5 of 5 · See all- K161024Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization TapeCanadian Technical Tape, Ltd. · 2016 · cites it directly2descendants
- K210553Steam-Dot Process IndicatorPropper Manufacturing Co., Inc. · 2021 · cites it directly1descendant
- K260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer Group · 2026 · 2 generations on0descendants
- K241036Autoclave Indicator Tape; EO Indicator TapeJiangmen New Era External Use Drug Co., Ltd. · 2024 · 2 generations on0descendants
- K191741Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization TapeIntertape Polymer, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001649 | Steritec Autoclave Tapes, Model CI122 & CI1234 | Steritec Products, Inc. | 2000 | — |
| 0 (this device) | 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 | — |
| +1 | K210553 | Steam-Dot Process Indicator | Propper Manufacturing Co., Inc. | 2021 | — |
| +2 | K260181 | LF Process Indicator Tape for Steam Sterilization | Intertape Polymer Group | 2026 | — |
| +2 | K241036 | Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. | 2024 | — |
| +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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K001649 | Steritec Autoclave Tapes, Model CI122 & CI1234Summary page 4…n Process Indicator Tape Physical/Chemical Sterilization Process Indicator JOJ Class I1, 21 CFR 880.2800(b) Sterilization Process Indicator Tapes Model CI122 & CI123 (K001649) SteriTec Products, Incorporated The process indicator tape distinguishes between items processed and unprocessed in both gravit… | 2000 |
What descends from it? (5)
3 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?
- Its one ancestor has no recall.
- Of its descendants, K161024 (Canadian Technical Tape, Ltd., 2016) has gone furthest, with 2 descendants of its own.
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. 2014, 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 Process Indicator Tape for Steam Sterilization 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140940 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140940: Process Indicator Tape for Steam Sterilization.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140940
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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