510(k) · Cleared

Cleared

Modification to: Attest Rapid Readout Biological Indicator, Mode 1292

K090569510(k) SpecialCleared Apr 29, 200958-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

3M Company · FRC Indicator, Biological Sterilization Process

Cleared on Apr 29, 2009 as substantially equivalent to K926364 (3M Health Care, Ltd., 1995) after a 58-day review. Its family tree reaches back 1 generation to 1995. 34 later devices descend from it.

Decided: Apr 29, 2009
Review: 58 days
Class: Class II
Product code: FRC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K926364 (1995). 34 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK926364 Attest Brand Rapid Readout Biological Ind. #129X3M Health Care, Ltd. · 1995
This deviceK090569 Modification to: Attest Rapid Readout Biological Indicator, Mode 12923M Company · 2009
Descendant · cites it directly · 31 of its ownK121484 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest…3M Company · 2012
Descendant · 2 generations on · 12 of its ownK140392 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company · 2014
Descendant · 3 generations on · 11 of its ownK152060 3M Attest Rapid Readout Biological Indicator 12953M Company · 2015
Descendant · 2 generations on · 11 of its ownK121593 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest…3M Company · 2013
Descendant · 3 generations on · 7 of its ownK173519 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super…3M Company · 2018 · Recalled

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2012high 8 (2018) · low 0 (2019)2026

Most influential descendants

Showing 5 of 34 · See all

K1214843M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader3M Company · 2012 · cites it directly31descendants
K1403923M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company · 2014 · 2 generations on12descendants
K1520603M Attest Rapid Readout Biological Indicator 12953M Company · 2015 · 3 generations on11descendants
K1215933M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super Rapid 5…3M Company · 2013 · 2 generations on11descendants
K1735193M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus…3M Company · 2018 · 3 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K926364	Attest Brand Rapid Readout Biological Ind. #129X	3M Health Care, Ltd.	1995	—
0 (this device)	K090569	Modification to: Attest Rapid Readout Biological Indicator, Mode 1292	3M Company	2009	—
+1	K121484	3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM)…	3M Company	2012	—
+2	K140392	3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader	3M Company	2014	—
+3	K152060	3M Attest Rapid Readout Biological Indicator 1295	3M Company	2015	—
+2	K121593	3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super…	3M Company	2013	—
+3	K173519	3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5…	3M Company	2018	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2014	1	0
2015	1	0
2016	2	0
2017	4	0
2018	8	0
2020	8	0
2021	1	0
2022	2	0
2024	5	0

FIG. 1 — Lineage of K090569, 1995–2024Source: 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
*	K926364	Attest Brand Rapid Readout Biological Ind. #129X Summary page 1 …lassification Name: Biological Sterilization Process Indicators 3. Identification of Predicate Device: 3MTM AttestTM Rapid Read-Out Biological Indicator (#1292), K926364 4. Device Description: The 3MTM AttestTM 1292 Rapid Readout Biological Indicator, RRBI, is a dual readout biologica…	3M Health Care, Ltd.	1995	—

Also cleared against K926364: 2 other devices →

What descends from it? (34)

See all 34

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K121484	3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader	3M Company	2012	31
K172432	SporView Rapid Read Biological Indicator	Crosstex/Spsmedical, A Division of Cantel Medical	2017	0
K151482	BCR-30-min BI™ and RBIP-ST30™ Readout Accessory	Bcr Diagnostics, Inc.	2016	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, K121484 (3M Company, 2012) has gone furthest, with 31 descendants of its own.
2 other devices also cite its predicate K926364.

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. 2009, this device’s year, is highlighted.

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?

Use the Attest 1292 RRBI to monitor:

1. 250°F (1210C) gravity steam sterilization cycles.

2. 270°F (1320C) vacuum assisted steam Sterilization cycles.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090569 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090569: Modification to: Attest Rapid Readout Biological Indicator, Mode 1292.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090569

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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