510(k) · Cleared
ClearedAti Disp. Biological Test Pack for Ethylene Oxide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pymah Corp., Ati Div. · FRC Indicator, Biological Sterilization Process
Cleared on Mar 8, 1990 after a 167-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Mar 8, 1990
- Review
- 167 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK895704 Ati Disp. Biological Test Pack for Ethylene OxidePymah Corp., Ati Div. · 1990
- Descendant · cites it directly · 5 of its ownK930683 Eztest-GasSgm Biomedical, Inc. · 1997
- Descendant · 2 generations on · 3 of its ownK151585 Andersen EOGas 4 SteriTestAndersen Sterilizers, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK202879 EOGas 4 Endo-SteriTest RRBIAndersen Sterilizers, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK192980 EOGas 4 Endo-SteriTestAndersen Sterilizers, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK170427 Anprolene SteriTestAndersen Sterilizers, Inc. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K930683Eztest-GasSgm Biomedical, Inc. · 1997 · cites it directly5descendants
- K151585Andersen EOGas 4 SteriTestAndersen Sterilizers, Inc. · 2015 · 2 generations on3descendants
- K202879EOGas 4 Endo-SteriTest RRBIAndersen Sterilizers, Inc. · 2021 · 3 generations on0descendants
- K192980EOGas 4 Endo-SteriTestAndersen Sterilizers, Inc. · 2020 · 3 generations on0descendants
- K170427Anprolene SteriTestAndersen Sterilizers, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895704 | Ati Disp. Biological Test Pack for Ethylene Oxide | Pymah Corp., Ati Div. | 1990 | — |
| +1 | K930683 | Eztest-Gas | Sgm Biomedical, Inc. | 1997 | — |
| +2 | K151585 | Andersen EOGas 4 SteriTest | Andersen Sterilizers, Inc. | 2015 | — |
| +3 | K202879 | EOGas 4 Endo-SteriTest RRBI | Andersen Sterilizers, Inc. | 2021 | — |
| +3 | K192980 | EOGas 4 Endo-SteriTest | Andersen Sterilizers, Inc. | 2020 | — |
| +3 | K170427 | Anprolene SteriTest | Andersen Sterilizers, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRC? 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 FRC device
- #1 K250044 Celerity 5 HP Biological Indicator (LCB052)…score 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K930683 (Sgm Biomedical, Inc., 1997) has gone furthest, with 5 descendants of its own.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRC
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRC
8so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRC
9in 2025
MAUDE reports naming product code FRC, 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 | 3 | 83 | 0 | 100 |
| 2008 | 1 | — | 0 | 60 |
| 2009 | 6 | 183 | 1 | 45 |
| 2010 | 4 | 165 | 0 | 57 |
| 2011 | 6 | 118 | 0 | 37 |
| 2012 | 9 | 178 | 2 | 46 |
| 2013 | 4 | 260 | 2 | 39 |
| 2014 | 13 | 174 | 0 | 51 |
| 2015 | 3 | 130 | 0 | 182 |
| 2016 | 2 | — | 0 | 482 |
| 2017 | 10 | 130 | 0 | 182 |
| 2018 | 18 | 97 | 0 | 22 |
| 2019 | 5 | 88 | 0 | 30 |
| 2020 | 10 | 150 | 0 | 16 |
| 2021 | 5 | 107 | 0 | 10 |
| 2022 | 5 | 193 | 4 | 9 |
| 2023 | 6 | 190 | 1 | 20 |
| 2024 | 8 | 105 | 0 | 22 |
| 2025 | 6 | 29 | 0 | 9 |
| 2026 | 1 | — | 8 | — |
https://510kreport.com/device/K895704 · printed Nov 5, 2026
Cite this page
510(k) Report. “K895704: Ati Disp. Biological Test Pack for Ethylene Oxide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K895704
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026