510(k) · Cleared
ClearedSteritec Autoclave Tapes, Model CI122 & CI1234
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steritec Products, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Jun 23, 2000 after a 24-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jun 23, 2000
- Review
- 24 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK001649 Steritec Autoclave Tapes, Model CI122 & CI1234Steritec Products, Inc. · 2000
- Descendant · cites it directly · 5 of its ownK140940 Process Indicator Tape for Steam SterilizationCanadian Technical Tape, Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK161024 Canadian Technical Tape, LTd. LF Process Indicator Steam…Canadian Technical Tape, Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK210553 Steam-Dot Process IndicatorPropper Manufacturing Co., Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK260181 LF Process Indicator Tape for Steam SterilizationIntertape Polymer Group · 2026
- Descendant · 3 generations on · 0 of its ownK241036 Autoclave Indicator Tape; EO Indicator TapeJiangmen New Era External Use Drug Co., Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K140940Process Indicator Tape for Steam SterilizationCanadian Technical Tape, Ltd. · 2014 · cites it directly5descendants
- K161024Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization TapeCanadian Technical Tape, Ltd. · 2016 · 2 generations on2descendants
- K210553Steam-Dot Process IndicatorPropper Manufacturing Co., Inc. · 2021 · 2 generations on1descendant
- K260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer Group · 2026 · 3 generations on0descendants
- K241036Autoclave Indicator Tape; EO Indicator TapeJiangmen New Era External Use Drug Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001649 | Steritec Autoclave Tapes, Model CI122 & CI1234 | Steritec Products, Inc. | 2000 | — |
| +1 | K140940 | Process Indicator Tape for Steam Sterilization | Canadian Technical Tape, Ltd. | 2014 | — |
| +2 | K161024 | Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape | Canadian Technical Tape, Ltd. | 2016 | — |
| +2 | K210553 | Steam-Dot Process Indicator | Propper Manufacturing Co., Inc. | 2021 | — |
| +3 | K260181 | LF Process Indicator Tape for Steam Sterilization | Intertape Polymer Group | 2026 | — |
| +3 | K241036 | Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140940 | Process Indicator Tape for Steam Sterilization | 2014 | 5 |
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, K140940 (Canadian Technical Tape, Ltd., 2014) has gone furthest, with 5 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.
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 | — |
https://510kreport.com/device/K001649 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001649: Steritec Autoclave Tapes, Model CI122 & CI1234.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001649
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026