510(k) · Cleared
ClearedSteri-Dot Process Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Propper Manufacturing Co., Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Jun 21, 2021 as substantially equivalent to K002861 (Steritec Products, Inc., 2000) after a 90-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jun 21, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002861 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK002861 EO Gas Sterilization Process Indicator Tapes, Model CI 124Steritec Products, Inc. · 2000
- This deviceK210866 Steri-Dot Process IndicatorPropper Manufacturing Co., Inc. · 2021
- Descendant · cites it directly · 0 of its ownK241036 Autoclave Indicator Tape; EO Indicator TapeJiangmen New Era External Use Drug Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241036Autoclave Indicator Tape; EO Indicator TapeJiangmen New Era External Use Drug Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002861 | EO Gas Sterilization Process Indicator Tapes, Model CI 124 | Steritec Products, Inc. | 2000 | — |
| 0 (this device) | K210866 | Steri-Dot Process Indicator | Propper Manufacturing Co., Inc. | 2021 | — |
| +1 | 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 |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K002861 | EO Gas Sterilization Process Indicator Tapes, Model CI 124Summary page 5…subject device (Steri-Dot process indicator, Propper Manufacturing Co., Inc) to Predicate device (EO Gas Sterilization Process Indicator Tapes, SteriTec Products, Inc., k002861). Product name Steri-Dot Process Indicator EO Gas Sterilization Similar. Both… | 2000 |
| † | K972747 | BI-O.K. EO Gas Biological Test-Pak (269305,269310,269320) | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241036 | Autoclave Indicator Tape; EO Indicator Tape | 2024 | 0 |
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?
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. 2021, 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 Steri-Dot Process Indicator for EO gas sterilization is designed for use by a health care 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 indicator dots turn from purple-red to green when exposed to EO gas sterilization conditions, thus providing an indication of processed items. The Steri-Dot process indicator can be used in…
Read the full statement (140 words)
The Steri-Dot Process Indicator for EO gas sterilization is designed for use by a health care 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 indicator dots turn from purple-red to green when exposed to EO gas sterilization conditions, thus providing an indication of processed items.
The Steri-Dot process indicator can be used in the following EO sterilization cycles:
1. 37°C, 736 mg/l EO, >35% RH, 3 hours exposure
2. 37°C, 759 mg/l EO, >35% RH, 3 hours exposure
3. 54°C, 600 mg/l EO, 40-60% RH, 45 min or longer exposure
4. 54°C, 736 mg/l EO, >35% RH, 1 hour exposure
5. 55°C, 759 mg/l EO, >35% RH, 1 hour exposure
6. 55°C, 600 mg/l EO, 40-60% RH, 4 hours exposure
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/K210866 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210866: Steri-Dot Process Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210866
Report an extraction error
Are you the manufacturer?
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