510(k) · Cleared
ClearedAutoclave Indicator Tape; EO Indicator Tape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangmen New Era External Use Drug Co., Ltd. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Dec 17, 2024 as substantially equivalent to K210553 (Propper Manufacturing Co., Inc., 2021) and 1 other predicate after a 245-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Dec 17, 2024
- Review
- 245 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001649 (2000). 5 ancestors in all. 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 backK210553 Steam-Dot Process IndicatorPropper Manufacturing Co., Inc. · 2021
- This deviceK241036 Autoclave Indicator Tape; EO Indicator TapeJiangmen New Era External Use Drug Co., Ltd. · 2024
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 | K210553 | Steam-Dot Process Indicator | Propper Manufacturing Co., Inc. | 2021 | — |
| 0 (this device) | K241036 | Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K210553 | Steam-Dot Process IndicatorSummary page 6…Page 1 of 8 C. Predicate device: 510(k) Number Trade Name Manufacturer K210553 Steam-Dot Process Indicator Propper Manufacturing Company, Inc. K210866 Steri-Dot® Proces… | 2021 |
| * | K210866 | Steri-Dot Process IndicatorSummary page 6…mber Trade Name Manufacturer K210553 Steam-Dot Process Indicator Propper Manufacturing Company, Inc. K210866 Steri-Dot® Process Indicator Propper Manufacturing Company, Inc. D. Indications for use of the devic… | 2021 |
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 24 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 5 ancestors has a recall.
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. 2024, 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?
Autoclave Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed and unprocessed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from yellow to Black. This is a single use, disposable device(s), and provided non-sterile. The Autoclave Indicator Tape can be used in the…
Read the full statement (172 words)
Autoclave Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed and unprocessed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from yellow to Black. This is a single use, disposable device(s), and provided non-sterile.
The Autoclave Indicator Tape can be used in the following steam sterilization cycles:
1. Gravity: 121℃, 30 minutes
2. Vacuum assisted (pre-vacuum): 134℃, 4 minutes
EO Indicator Tape is designed for use by a healthcare provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process and to distinguish between processed and unprocessed units or loads. The chemical indicator lines turn from Orange to Green when exposed to EO gas sterilization conditions. This is a single use, disposable device(s), and provided non-sterile.
The EO Indicator Tape can be used in the following EO sterilization cycle:
55℃, 762mg/l EO, 40~80%RH, 4 hours exposure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241036: Autoclave Indicator Tape; EO Indicator Tape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241036
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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