510(k) · Cleared

Cleared

Verify V-Pro Chemical Indicator, Versions 1 and 2

K072510510(k) AbbreviatedCleared Dec 11, 200796-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 Dec 11, 2007 as substantially equivalent to K994055 (Advanced Sterilization Products, 2002) after a 96-day review. Its family tree reaches back 1 generation to 2002. 10 later devices descend from it.

Decided: Dec 11, 2007
Review: 96 days
Class: Class II
Product code: JOJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K994055 (2002). 10 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
This deviceK072510 Verify V-Pro Chemical Indicator, Versions 1 and 2STERIS Corporation · 2007
Descendant · cites it directly · 9 of its ownK091174 Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical…STERIS Corporation · 2009
Descendant · 2 generations on · 7 of its ownK140515 Verify Hpu Chemical Indicator/ Verify Vaporized VH202 Process…STERIS Corporation · 2014
Descendant · 3 generations on · 6 of its ownK172746 VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process…STERIS Corporation · 2018
Descendant · 4 generations on · 5 of its ownK183295 Celerity HP Chemical Indicator (CI)Steris Corporations · 2019
Descendant · 5 generations on · 4 of its ownK192020 Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process…STERIS Corporation · 2019

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009high 2 (2014) · low 0 (2010)2026

Most influential descendants

Showing 5 of 10 · See all

K091174Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical Indicator; Version…STERIS Corporation · 2009 · cites it directly9descendants
K140515Verify Hpu Chemical Indicator/ Verify Vaporized VH202 Process Indicator Adhesive LabelSTERIS Corporation · 2014 · 2 generations on7descendants
K172746VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive…STERIS Corporation · 2018 · 3 generations on6descendants
K183295Celerity HP Chemical Indicator (CI)Steris Corporations · 2019 · 4 generations on5descendants
K192020Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive…STERIS Corporation · 2019 · 5 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K994055	Sterrad Cyclesure Biological Indicator	Advanced Sterilization Products	2002	1
0 (this device)	K072510	Verify V-Pro Chemical Indicator, Versions 1 and 2	STERIS Corporation	2007	—
+1	K091174	Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical Indicator…	STERIS Corporation	2009	—
+2	K140515	Verify Hpu Chemical Indicator/ Verify Vaporized VH202 Process Indicator…	STERIS Corporation	2014	—
+3	K172746	VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator…	STERIS Corporation	2018	—
+4	K183295	Celerity HP Chemical Indicator (CI)	Steris Corporations	2019	—
+5	K192020	Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator…	STERIS Corporation	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2014	2	0
2018	1	0
2019	2	0
2023	2	0
2024	2	0

FIG. 1 — Lineage of K072510, 2002–2024Source: 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 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 K261992 3M™ Attest™ Steam Chemical Integrator (1243A…score 13.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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
*	K994055	Sterrad Cyclesure Biological Indicator Summary page 2 …880.2800 (b), Product Code JOJ). 2. Predicate Device Chemical Indicator Component of the STERRAD®9 CycleSure~m Biological Indicator (K994055) 3. Device Description The Verify® V-PRO Chemical Indicator is used in each processing cycle to indicate exp…	Advanced Sterilization Products	2002	1

Also cleared against K994055: 4 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K091174	Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical Indicator; Version…	STERIS Corporation	2009	9

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 a recall.
Of its descendants, K091174 (STERIS Corporation, 2009) has gone furthest, with 9 descendants of its own.
4 other devices also cite its predicate K994055.

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. 2007, this device’s year, is highlighted.

FDA decisions per year · JOJ

6in 2025

2007high 13 (2011) · low 4 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOJ

90in 2025

2007high 224 (2012) · low 38 (2019)2026

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

Recalls per year · JOJ

1in 2023

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	140	0	1
2008	9	57	2	1
2009	7	188	2	9
2010	6	115	0	3
2011	13	151	2	1
2012	7	224	0	8
2013	6	212	0	6
2014	6	198	0	11
2015	8	188	0	7
2016	4	150	0	11
2017	7	172	0	35
2018	5	150	0	12
2019	12	38	0	8
2020	7	108	0	6
2021	4	87	1	29
2022	8	90	0	23
2023	4	53	1	39
2024	12	71	0	25
2025	6	90	0	12
2026	3	30	0	—

What is it indicated for?

The Verify® V-PRO Chemical Indicator (Version 1) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2) are Class 1 vaporized hydrogen peroxide sterilization process indicators. They are designed to distinguish between processed and unprocessed units when placed within (Version 1) or affixed to (Version 2) sterilization wraps, trays or pouches to indicate, through a visible change from magenta to yellow, when the device (Version 1) or pack (Version 2) has been exposed to a V-PRO 1 sterilization process. This product is designed for use exclusively in the Amsco V-PRO 1 Low Temperature Sterilization system at 50 °C using Vaprox TM HC Sterilant.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072510 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072510: Verify V-Pro Chemical Indicator, Versions 1 and 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072510

Report an extraction error

Are you the manufacturer?

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