510(k) · Cleared
ClearedSterrad BI Test Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Sterilization Products · FRC Indicator, Biological Sterilization Process
Cleared on Jun 1, 2000 as substantially equivalent to K921909 (Johnson & Johnson Medical, Inc., 1993) and 1 other predicate after a 206-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jun 1, 2000
- Review
- 206 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K921909 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (2)
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 |
|---|---|---|---|
| * | K921909 | Sterrad BI Test PackSummary page 1…STERRAD® BI Test Pack Common Name Biological Indicator (Challenge Pack) Classification Name Class II Legally Marketed Equivalent Device Name(s) STERRAD® BI Test Pack, K921909, October 1, 1993 as modified in K991675, June 15, 1999. DIVISION OF ETHICON, INC. ¢ 33 TECHNOLOGY DRIVE « IRVINE, CA 92618 « (94… | 1993 |
| * | K991675 | Modification of: Sterrad BI Test PackSummary page 1…gical Indicator (Challenge Pack) Classification Name Class II Legally Marketed Equivalent Device Name(s) STERRAD® BI Test Pack, K921909, October 1, 1993 as modified in K991675, June 15, 1999. DIVISION OF ETHICON, INC. ¢ 33 TECHNOLOGY DRIVE « IRVINE, CA 92618 « (949) 581-5799 FAX (949) 789-3900 510(k) S… | 1999 |
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 7 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K921909.
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 STERRAD®BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles. It functions as a routine test pack with both a biological sterilization process indicator and a chemical process indicator.
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/K993775 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993775: Sterrad BI Test Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993775
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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