510(k) · Cleared
ClearedSteritec Disposable Biological Test Pack-EO Gas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steritec Products Mfg Co, Inc. · FRC Indicator, Biological Sterilization Process
Cleared on Oct 29, 1998 as substantially equivalent to K895704 (Pymah Corp., Ati Div., 1990) after a 185-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Oct 29, 1998
- Review
- 185 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895704 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK895704 Ati Disp. Biological Test Pack for Ethylene OxidePymah Corp., Ati Div. · 1990
- This deviceK981497 Steritec Disposable Biological Test Pack-EO GasSteritec Products Mfg Co, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895704 | Ati Disp. Biological Test Pack for Ethylene Oxide | Pymah Corp., Ati Div. | 1990 | — |
| 0 (this device) | K981497 | Steritec Disposable Biological Test Pack-EO Gas | Steritec Products Mfg Co, Inc. | 1998 | — |
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 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? (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 |
|---|---|---|---|
| * | K895704 | Ati Disp. Biological Test Pack for Ethylene OxideSummary page 2…Co., Inc. 510(k) Summary - continued Identification of Predicate device: The predicate device is the ATI Disposable Biological Test Pack for Ethylene Oxide, (510(k) # 895704) manufactured and distributed by ATI-PyMaH now owned by 3M Corporation. Description of S10(k) submission device: Product Descri… | 1990 |
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 K895704.
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 | — |
What is it indicated for?
The Steritec Disposable EO Biological Test Pack is designed specifically for biological testing
of EO gas sterilizers. The performance specifications for this product are 130 F, 45% to 60%
Relative Humidity, 600 mg/L EO gas with all survivors at 15 minutes and all killed at 60
minutes.
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/K981497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981497: Steritec Disposable Biological Test Pack-EO Gas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981497
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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