510(k) · Cleared
ClearedAN87 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 1, 2017 as substantially equivalent to K150645 (Andersen Sterilizers, Inc., 2015) after a 261-day review. Its family tree reaches back 1 generation to 2015.
- Decided
- Nov 1, 2017
- Review
- 261 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 deviceK170439 AN87 DosimeterAndersen Sterilizers, Inc. · 2017
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) | K170439 | AN87 Dosimeter | Andersen Sterilizers, Inc. | 2017 | — |
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 5…Product Code JOJ 5.5 Predicate Device Device Name AN1087 Dosimeter® 510(k) number K150645 Manufacturer Andersen Sterilizers, Inc. The predicate AN1087 Dosimeters are approved for use wit… | 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. 2017, 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?
AN87 Dosimeter is a single-use color change chemical indicator that is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. Critical process parameters for the cycle are summarized in Table 1. Table 1. Critical sterilization cycle parameters in the Anprolene AN75…
Read the full statement (92 words)
AN87 Dosimeter is a single-use color change chemical indicator that is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc.
Critical process parameters for the cycle are summarized in Table 1.
Table 1. Critical sterilization cycle parameters in the Anprolene AN75 Ethylene Oxide Gas Sterilizer
Ethylene Oxide Temperature Relative Humidity Ethylene Oxide Exposure Time Total Cycle Time
17.6 g ± 5% 20-29°C 35-90% 12 hours 14 hours
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170439: AN87 Dosimeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170439
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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