510(k) · Cleared
Recalled · Class II · 2013Verify 270FP Challenge Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Mar 10, 2011 as substantially equivalent to K073683 (STERIS Corporation, 2008) and 1 other predicate after a 146-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 10, 2011
- Review
- 146 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K932129 (1994). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK932129 3M Autoclave Tapes3M Company · 1994
- 3 generations backK992767 Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2000
- 2 generations backK032801 Modified Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2003
- 1 generation backK073683 Verify Challenge Packs - Version 2STERIS Corporation · 2008
- This deviceK103053 Verify 270FP Challenge PackSTERIS Corporation · 2011
- Descendant · cites it directly · 0 of its ownK162758 VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators…STERIS Corporation · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K162758VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test…STERIS Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932129 | 3M Autoclave Tapes | 3M Company | 1994 | — |
| −3 | K992767 | Browne Packaging and Label Steam Process Indicator | Albert Browne, Ltd. | 2000 | — |
| −2 | K032801 | Modified Browne Packaging and Label Steam Process Indicator | Albert Browne, Ltd. | 2003 | — |
| −1 | K073683 | Verify Challenge Packs - Version 2 | STERIS Corporation | 2008 | — |
| 0 (this device) | K103053 | Verify 270FP Challenge Pack | STERIS Corporation | 2011 | — |
| +1 | K162758 | VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie… | STERIS Corporation | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073683 | Verify Challenge Packs - Version 2Summary page 2…indicator (21 CFR 880.2800 (b), Product Code JOJ). 2. Predicate Device * STERIS Verify®Challenge Pack (Model 270F 4) - K073683 * Getinge ChemSix Test Pack - K080136 3. Device Description The proposed Verify® 270FP Challenge Pack consists… | 2008 |
| * | K080136 | Instant Readout Chemical Integrator Challenge Pack, Model LT- 105Summary page 2…CFR 880.2800 (b), Product Code JOJ). 2. Predicate Device * STERIS Verify®Challenge Pack (Model 270F 4) - K073683 * Getinge ChemSix Test Pack - K080136 3. Device Description The proposed Verify® 270FP Challenge Pack consists of three emulating indicator inks situate… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162758 | VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test… | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2013 | Class II | Z-1166-2014 | Labeling False and Misleading | STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY¿ SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K162758 (STERIS Corporation, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K073683.
How does its category compare?
All JOJ devicesJOJ Indicator, Physical/Chemical 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 · JOJ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOJ
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOJ
12in 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® 270FP Challenge Pack is a test pack consisting of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier, intended for use in SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization. The Verify® 270FP Challenge Pack indicators change color from yellow to blue/purple when exposed to the following conditions at 270'F (I132 0 C):
* 4 minute indicator - SFPP and pre-vacuum steam sterilization for 4 minutes.
* 10 minute indicator - Pre-vacuum steam sterilization for 10 minutes.
* 20 minute indicator - Pre-vacuum steam sterilization for 20 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103053: Verify 270FP Challenge Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103053
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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