510(k) Report

510(k) · Cleared

Cleared

3M Autoclave Tapes

K932129510(k) TraditionalCleared Mar 4, 1994305-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 · JOJ Indicator, Physical/Chemical Sterilization Process

Cleared on Mar 4, 1994 after a 305-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.

Decided
Mar 4, 1994
Review
305 days
Class
Class II
Product code
JOJ
Recalls
None
Predicates
0

15 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2010: 1 descendant cleared2000: 1 descendant cleared2024: 1 descendant cleared2019: 1 descendant cleared2022: 2 descendants cleared2003: 1 descendant cleared2006: 2 descendants cleared2008: 1 descendant cleared2025: 1 descendant cleared2012: 1 descendant cleared2017: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK932129 3M Autoclave Tapes3M Company · 1994
  2. Descendant · cites it directly · 7 of its ownK992767 Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2000
  3. Descendant · 2 generations on · 6 of its ownK032801 Modified Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2003
  4. Descendant · cites it directly · 5 of its ownK101528 3M Comply Lead Free Process Indicators for Steam3M Company · 2010 · Recalled
  5. Descendant · 3 generations on · 2 of its ownK073683 Verify Challenge Packs - Version 2STERIS Corporation · 2008
  6. Descendant · 3 generations on · 2 of its ownK060103 Albert Browne LTD. Verify Steam Value IndicatorsAlbert Browne, Ltd. · 2006

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2000: 12003: 12006: 22008: 12010: 12011: 12012: 12017: 12018: 12019: 12022: 22024: 12025: 1
2000high 2 (2006) · low 0 (2001)2026

Most influential descendants

Showing 5 of 15 · See all
  • K992767Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2000 · cites it directly7descendants
  • K032801Modified Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2003 · 2 generations on6descendants
  • K1015283M Comply Lead Free Process Indicators for Steam3M Company · 2010 · cites it directly5descendants
  • K073683Verify Challenge Packs - Version 2STERIS Corporation · 2008 · 3 generations on2descendants
  • K060103Albert Browne LTD. Verify Steam Value IndicatorsAlbert Browne, Ltd. · 2006 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K9321293M Autoclave Tapes3M Company1994—
+1K992767Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd.2000—
+2K032801Modified Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd.2003—
+1K1015283M Comply Lead Free Process Indicators for Steam3M Company20101
+3K073683Verify Challenge Packs - Version 2STERIS Corporation2008—
+3K060103Albert Browne LTD. Verify Steam Value IndicatorsAlbert Browne, Ltd.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200310
200620
200810
201010
201110
201210
201710
201810
201910
202220
202410
202510
FIG. 1 — Lineage of K932129, 1994–2025Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JOJ? 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 JOJ device

  1. #1 K261992 3M™ Attest™ Steam Chemical Integrator (1243A…score 13.3 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K992767Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd.20007
K1015283M Comply Lead Free Process Indicators for Steam3M Company20105
K171823U&U Indicator tape and stripU&U Medical Technology Co, Ltd.20180

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?

  • Of its descendants, K992767 (Albert Browne, Ltd., 2000) has gone furthest, with 7 descendants of its own.

How does its category compare?

All JOJ devices

JOJ Indicator, Physical/Chemical Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOJ

6in 2025

2007: 82008: 92009: 72010: 62011: 132012: 72013: 62014: 62015: 82016: 42017: 72018: 52019: 122020: 72021: 42022: 82023: 42024: 122025: 62026 (partial year): 3
2007high 13 (2011) · low 4 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOJ

90in 2025

2007: 140 days median2008: 57 days median2009: 188 days median2010: 115 days median2011: 151 days median2012: 224 days median2013: 212 days median2014: 198 days median2015: 188 days median2016: 150 days median2017: 172 days median2018: 150 days median2019: 38 days median2020: 108 days median2021: 87 days median2022: 90 days median2023: 53 days median2024: 71 days median2025: 90 days median2026 (partial year): 30 days median
2007high 224 (2012) · low 38 (2019)2026

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

Recalls per year · JOJ

1in 2023

2008: 22009: 22011: 22021: 12023: 1
2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JOJ

12in 2025

2007: 12008: 12009: 92010: 32011: 12012: 82013: 62014: 112015: 72016: 112017: 352018: 122019: 82020: 62021: 292022: 232023: 392024: 252025: 12
2007high 39 (2023) · low 1 (2007)2025

MAUDE reports naming product code JOJ, 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
2007814001
200895721
2009718829
2010611503
20111315121
2012722408
2013621206
20146198011
2015818807
20164150011
20177172035
20185150012
2019123808
2020710806
2021487129
2022890023
2023453139
20241271025
2025690012
20263300—
Cite this page

510(k) Report. “K932129: 3M Autoclave Tapes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K932129

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026