510(k) Report

510(k) · Cleared

Cleared

VERIFY VH202 Indicator Tape

K183293510(k) TraditionalCleared Jan 4, 201938-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

STERIS Corporation · JOJ Indicator, Physical/Chemical Sterilization Process

Cleared on Jan 4, 2019 after a 38-day review. The FDA summary names no predicate by number. 3 later devices descend from it.

Decided
Jan 4, 2019
Review
38 days
Class
Class II
Product code
JOJ
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2023: 1 descendant cleared2024: 2 descendants cleared201620182020202220242026
  1. This deviceK183293 VERIFY VH202 Indicator TapeSTERIS Corporation · 2019
  2. Descendant · cites it directly · 2 of its ownK231488 Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical…Steris · 2023
  3. Descendant · 2 generations on · 1 of its ownK240760 CELERITY HP Indicator TapeSteris · 2024
  4. Descendant · 3 generations on · 0 of its ownK242189 CELERITY HP Indicator Tape (PCC077)Steris · 2024

Most influential descendants

Showing 3 of 3 · See all
  • K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY…Steris · 2023 · cites it directly2descendants
  • K240760CELERITY HP Indicator TapeSteris · 2024 · 2 generations on1descendant
  • K242189CELERITY HP Indicator Tape (PCC077)Steris · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K183293VERIFY VH202 Indicator TapeSTERIS Corporation2019—
+1K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical…Steris2023—
+2K240760CELERITY HP Indicator TapeSteris2024—
+3K242189CELERITY HP Indicator Tape (PCC077)Steris2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202420
FIG. 1 — Lineage of K183293, 2019–2024Source: 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 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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY…Steris20232

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, K231488 (Steris, 2023) has gone furthest, with 2 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. 2019, this device’s year, is highlighted.

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. “K183293: VERIFY VH202 Indicator Tape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K183293

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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