510(k) · Cleared

Cleared

Modification of: Sterrad BI Test Pack

K991675510(k) SpecialCleared Jun 15, 199929-day reviewClass II21 CFR 880.2800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Advanced Sterilization Products · FRC Indicator, Biological Sterilization Process

Cleared on Jun 15, 1999 as substantially equivalent to K921909 (Johnson & Johnson Medical, Inc., 1993) after a 29-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Jun 15, 1999
Review: 29 days
Class: Class II
Product code: FRC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K921909 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK921909 Sterrad BI Test PackJohnson & Johnson Medical, Inc. · 1993
This deviceK991675 Modification of: Sterrad BI Test PackAdvanced Sterilization Products · 1999
Descendant · cites it directly · 0 of its ownK993775 Sterrad BI Test PackAdvanced Sterilization Products · 2000

Most influential descendants

Showing 1 of 1 · See all

K993775Sterrad BI Test PackAdvanced Sterilization Products · 2000 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K921909	Sterrad BI Test Pack	Johnson & Johnson Medical, Inc.	1993	—
0 (this device)	K991675	Modification of: Sterrad BI Test Pack	Advanced Sterilization Products	1999	—
+1	K993775	Sterrad BI Test Pack	Advanced Sterilization Products	2000	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K991675, 1993–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K921909	Sterrad BI Test Pack Summary 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. DIVISION OF ETHICON, INC. « 33 TECHNOLOGY DRIVE - IRVINE, CA 92618 « (949) 581-5799 FAX (949) 789-3900 (Divis…	Johnson & Johnson Medical, Inc.	1993	—

Also cleared against K921909: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K993775	Sterrad BI Test Pack	Advanced Sterilization Products	2000	0

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.
Of its descendants, K993775 (Advanced Sterilization Products, 2000) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K921909.

How does its category compare?

All FRC devices

FRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRC

6in 2025

2007high 18 (2018) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRC

29in 2025

2007high 260 (2013) · low 29 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRC

8so far in 2026, the most since 2007

2007high 8 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FRC

9in 2025

2007high 482 (2016) · low 9 (2022)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® 100 Sterilizer cycle*, It functions as a routine test pack with both a biological sterilization process indicator and a chernical process indicator. Catalase Reagent is added to the Tryptic Soy Broth (TSB) medium, to neutralize the residual hydrogen peroxide on the biological indictor strip after sterilization. * See precautionary statement in…

Read the full statement (185 words)

Catalase Reagent is added to the Tryptic Soy Broth (TSB) medium, to neutralize the residual hydrogen peroxide on the biological indictor strip after sterilization.

* See precautionary statement in Instructions For Use concemning the use of this product with the STERRAD 50 Sterilizer which reads in part as follows:

NOTE: The Certificate of Performance that accompanies these BI Test Packs contains data from the STERRAD® 100 Sterilizer. This information is unique to the STERRAD® 100 Sterilizer. The initial validation data submitted, based upon varying hydrogen peroxide concentration in the STERRAD® 50 Sterilizer, indicate that the BI Test Pack is acceptable for use with the STERRAD® 50 Sterilizer. The final performance data (D-value and Survival/Kill times) are not yet complete. Updated performance data for the BI Test Pack in the STERRAD® 50 Sterilizer will be provided by ASP as soon as it is available.

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/K991675 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991675: Modification of: 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/K991675

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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