510(k) · Cleared
ClearedClassix Chemical Sterilization Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Propper Mfg. Co., Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on May 25, 2011 as substantially equivalent to K895910 (Propper Mfg. Co., Inc., 1990) and 2 other predicates after a 237-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- May 25, 2011
- Review
- 237 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K801109 (1980). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK801109 Proof (Biological/Chemical Indicator)Amsco Co. · 1980
- 2 generations backK963841 EztestSgm Biotech, Inc. · 1997 · Recalled
- 1 generation backK071895 Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007
- This deviceK102894 Classix Chemical Sterilization IndicatorPropper Mfg. Co., Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801109 | Proof (Biological/Chemical Indicator) | Amsco Co. | 1980 | — |
| −2 | K963841 | Eztest | Sgm Biotech, Inc. | 1997 | 1 |
| −1 | K071895 | Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator | STERIS Corporation | 2007 | — |
| 0 (this device) | K102894 | Classix Chemical Sterilization Indicator | Propper Mfg. Co., Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 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? (3)
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 |
|---|---|---|---|
| * | K895910 | SteamlineSummary page 2…Em u-C Itex Predicate device 510Ok number vai-sioii 121 0C-20niin Propper Vapor Line indicator K895910 132"C,- 4 mmni Stei is VerifPy indicator K(071895 135TC - 3 min Steris Verify indicator… | 1990 |
| * | K071895 | Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSummary page 2…510Ok number vai-sioii 121 0C-20niin Propper Vapor Line indicator K895910 132"C,- 4 mmni Stei is VerifPy indicator K(071895 135TC - 3 min Steris Verify indicator K070461 SLSubsantial equivalecec to the predica… | 2007 |
| * | K070461 | Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4Summary page 2…ndicator K895910 132"C,- 4 mmni Stei is VerifPy indicator K(071895 135TC - 3 min Steris Verify indicator K070461 SLSubsantial equivalecec to the predicate device was evaluated accordling to the FDA guidance doc… | 2007 |
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 31 years and passes through 4 companies; a new generation was cleared every 10.7 years on median.
- 3 of the 12 ancestors have a recall of any class.
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. 2011, 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 Emu-Chex Sterilization Indicator is an emulating indicator intended to be used by a health care provider to monitor steam sterilization processes. Emu-Chex Sterilization Indicator comes in three varieties: for use in a gravity steam sterilization process operating at 121°C for 20 minutes, for use in pre-vacuum steam sterilization processes operating at 132°C for 4 minutes and 135°C for 3 minutes, The Emu-Chex Sterilization Indicators can be placed…
Read the full statement (105 words)
The Emu-Chex Sterilization Indicator is an emulating indicator intended to be used by a health care provider to monitor steam sterilization processes. Emu-Chex Sterilization Indicator comes in three varieties: for use in a gravity steam sterilization process operating at 121°C for 20 minutes, for use in pre-vacuum steam sterilization processes operating at 132°C for 4 minutes and 135°C for 3 minutes,
The Emu-Chex Sterilization Indicators can be placed together with items to be steam sterilized. The indicator changes color from blue-green to brown when the sterilization cycle is complete. The performance of the Emu-Chex Sterilization Indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating indicators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102894: Classix Chemical Sterilization Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102894
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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