510(k) · Cleared
ClearedAN1036 Dosimeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andersen Sterilizers, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Nov 12, 2020 as substantially equivalent to K150645 (Andersen Sterilizers, Inc., 2015) after a 275-day review. Its family tree reaches back 1 generation to 2015.
- Decided
- Nov 12, 2020
- Review
- 275 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K150645 (2015). No later device cites it as a predicate yet.
- Root · 1 generation backK150645 AN1087 DosimeterAndersen Sterilizers, Inc. · 2015
- This deviceK200334 AN1036 DosimeterAndersen Sterilizers, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K150645 | AN1087 Dosimeter | Andersen Sterilizers, Inc. | 2015 | — |
| 0 (this device) | K200334 | AN1036 Dosimeter | Andersen Sterilizers, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K150645 | AN1087 DosimeterSummary page 4…vironmental Protection Agency (EPA #69340-7). Predicate Device Device Name AN1087 Dosimeter 510(k) number K150645 Manufacturer Andersen Sterilizers, Inc. The predicate AN1087 Dosimeters were cleared for use with… | 2015 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K150645.
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. 2020, 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?
AN1036 Dosimeter is a single-use color change chemical indicator. It is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in a 3-hour or 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc.
Critical process parameters for the cycles are summarized in Table 1.
Table 1. Critical sterilization cycle parameters in the EOGas 4 Ethylene Oxide Gas Sterilizer
Ethylene Oxide Temperature Relative Humidity EO Exposure Time Total Cycle Time
17.6 g £ 5% 50°C = 3°C 35-70% 3 hours 3.5 hours
6 hours 7 hours
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/K200334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200334: AN1036 Dosimeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200334
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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