510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader

K103277510(k) TraditionalCleared Apr 19, 2011165-day reviewClass II21 CFR 880.2800Recalls 1

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

3M Company-3M Health Care · FRC Indicator, Biological Sterilization Process

Cleared on Apr 19, 2011 as substantially equivalent to K900771 (3M Company, 1990) and 1 other predicate after a 165-day review. Its family tree reaches back 1 generation to 1990. 35 later devices descend from it. It has been recalled once.

Decided
Apr 19, 2011
Review
165 days
Class
Class II
Product code
FRC
Recalls
1
Predicates
2

Its longest line of descent runs back 1 generation to K900771 (1990). 2 ancestors in all. 35 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2016: 2 descendants cleared2012: 1 descendant cleared2021: 2 descendants cleared2014: 1 descendant cleared2018: 9 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared2017: 3 descendants cleared2024: 5 descendants cleared2020: 8 descendants cleared2022: 2 descendants clearedK900771 · Attest Brand Rapid Readout Biological Indicator · 3M Company · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 6 descendants3 generations forward: 11 descendants4 generations forward: 5 descendants5 generations forward: 6 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant K900771 · Attest Brand Rapid Readout Biological Indicator · 3M Company · 19900+5
  1. Root · 1 generation backK900771 Attest Brand Rapid Readout Biological Indicator3M Company · 1990
  2. This deviceK103277 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest…3M Company-3M Health Care · 2011
  3. Descendant · cites it directly · 31 of its ownK121484 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest…3M Company · 2012
  4. Descendant · cites it directly · 12 of its ownK140392 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company · 2014
  5. Descendant · 2 generations on · 11 of its ownK152060 3M Attest Rapid Readout Biological Indicator 12953M Company · 2015
  6. Descendant · 2 generations on · 11 of its ownK121593 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest…3M Company · 2013
  7. 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 35 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 12015: 12016: 22017: 32018: 92020: 82021: 22022: 22024: 5
2012high 9 (2018) · low 0 (2019)2026

Most influential descendants

Showing 5 of 35 · 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 · cites it directly12descendants
  • K1520603M Attest Rapid Readout Biological Indicator 12953M Company · 2015 · 2 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

GenerationNumberDeviceApplicantDecidedRecalls
−1K900771Attest Brand Rapid Readout Biological Indicator3M Company1990—
0 (this device)K1032773M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490…3M Company-3M Health Care2011—
+1K1214843M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM)…3M Company2012—
+1K1403923M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company2014—
+2K1520603M Attest Rapid Readout Biological Indicator 12953M Company2015—
+2K1215933M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super…3M Company2013—
+3K1735193M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5…3M Company20181

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201410
201510
201620
201730
201890
202080
202120
202220
202450
FIG. 1 — Lineage of K103277, 1990–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250044 Celerity 5 HP Biological Indicator (LCB052)…score 14.5 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K900771Attest Brand Rapid Readout Biological Indicator3M Company1990—
*K0040093M Attest 290 Auto-Reader
Summary page 5
…t to the predicate devices, the 3MTM AtteStTM 1291 Rapid Readout Biological Indicator for Steam, cleared under K90077 I, and 3MTM AttcStrM 290 Auto-reader, cleared under K004009, in terms of their intended use, physical properties and technological characteristics. There are no new questions of safety or e…
3M Company2002—

What descends from it? (35)

See all 35

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

NumberDeviceApplicantDecidedDescendants
K1214843M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader3M Company201231
K1403923M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company201412
K202721Celerity 20 Steam Biological Indicator for IUSSSTERIS Corporation20210
K1735843M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest…3M Company20180
K151482BCR-30-min BI™ and RBIP-ST30™ Readout AccessoryBcr Diagnostics, Inc.20160

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 9, 2014Class IIZ-2002-2014Labeling Change ControlLabeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry natural rubber" as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K121484 (3M Company, 2012) has gone furthest, with 31 descendants of its own.

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. 2011, this device’s year, is highlighted.

FDA decisions per year · FRC

6in 2025

2007: 32008: 12009: 62010: 42011: 62012: 92013: 42014: 132015: 32016: 22017: 102018: 182019: 52020: 102021: 52022: 52023: 62024: 82025: 62026 (partial year): 1
2007high 18 (2018) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRC

29in 2025

2007: 83 days median2009: 183 days median2010: 165 days median2011: 118 days median2012: 178 days median2013: 260 days median2014: 174 days median2015: 130 days median2017: 130 days median2018: 97 days median2019: 88 days median2020: 150 days median2021: 107 days median2022: 193 days median2023: 190 days median2024: 105 days median2025: 29 days median
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

2009: 12012: 22013: 22022: 42023: 12026 (partial year): 8
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

2007: 1002008: 602009: 452010: 572011: 372012: 462013: 392014: 512015: 1822016: 4822017: 1822018: 222019: 302020: 162021: 102022: 92023: 202024: 222025: 9
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073830100
20081—060
20096183145
20104165057
20116118037
20129178246
20134260239
201413174051
201531300182
20162—0482
2017101300182
20181897022
2019588030
202010150016
20215107010
2022519349
20236190120
20248105022
202562909
20261—8—

What is it indicated for?

Use the 3M Attest 1491 Super Rapid Readout Biological Indicator in conjunction with the 3M Attest 490 Auto-reader to monitor the cycles below.

Sterilization Type: Gravity Displacement; Temperature: 270°F (132°C); Time: 3 minutes

Immediate Use Steam Sterilization Cycle (Flash); Temperature: 270°F (132°C); Time: 10 minutes

Temperature: 275°F (135°C); Time: 3 minutes

Temperature: 275°F (135°C); Time: 10 minutes

The 3M Attest 1491 Super Rapid Readout Biological Indicator provides a final fluorescent result in 30 minutes. An optional visual pH color change result is observed in 24 hours.

Indications for use as stated in the FDA summary.

More from 3M Company-3M Health Care

2 FDA decisions under this applicant name. See the company

  • K080620Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 20081 recall

Recent decisions in FRC

The FRC category page

  • K260766Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation · 2026
  • K252680Celerity™ 20 HP Biological IndicatorSTERIS Corporation · 2025
  • K251122Terragene® Bionova® BT20 Biological IndicatorTerragene · 2025
  • K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP…Steris · 2025
  • K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP…STERIS Corporation · 2025

https://510kreport.com/device/K103277 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103277: 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103277

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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