510(k) · Cleared
ClearedVERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FRC Indicator, Biological Sterilization Process
Cleared on Feb 28, 2018 as substantially equivalent to K133267 (Dana Products, Inc., 2014) after a 96-day review. Its family tree reaches back 1 generation to 2014. 2 later devices descend from it.
- Decided
- Feb 28, 2018
- Review
- 96 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K133267 (2014). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK133267 Dana Reusable Test PackDana Products, Inc. · 2014
- This deviceK173633 VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM…STERIS Corporation · 2018
- Descendant · cites it directly · 1 of its ownK182931 VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM…Steris Corporations · 2018
- Descendant · 2 generations on · 0 of its ownK243501 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack…3M Company · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K133267 | Dana Reusable Test Pack | Dana Products, Inc. | 2014 | — |
| 0 (this device) | K173633 | VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable… | STERIS Corporation | 2018 | — |
| +1 | K182931 | VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable… | Steris Corporations | 2018 | — |
| +2 | K243501 | 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE… | 3M Company | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 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 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 K250044 Celerity 5 HP Biological Indicator (LCB052)…score 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K133267 | Dana Reusable Test PackSummary page 5…Class II Classification Name: Indicator, Biological Sterilization Process (21 CFR 880.2800, FRC) 2. Predicate Device K133267 Dana Reusable Test Pack 3. Description of Device The VERIFY All-in-One STEAM Reusable Test Pack (formerly identifi… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182931 | VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack… | 2018 | 1 |
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 no recall.
- Of its descendants, K182931 (Steris Corporations, 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FRC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRC
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRC
8so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRC
9in 2025
MAUDE reports naming product code FRC, 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 | 3 | 83 | 0 | 100 |
| 2008 | 1 | — | 0 | 60 |
| 2009 | 6 | 183 | 1 | 45 |
| 2010 | 4 | 165 | 0 | 57 |
| 2011 | 6 | 118 | 0 | 37 |
| 2012 | 9 | 178 | 2 | 46 |
| 2013 | 4 | 260 | 2 | 39 |
| 2014 | 13 | 174 | 0 | 51 |
| 2015 | 3 | 130 | 0 | 182 |
| 2016 | 2 | — | 0 | 482 |
| 2017 | 10 | 130 | 0 | 182 |
| 2018 | 18 | 97 | 0 | 22 |
| 2019 | 5 | 88 | 0 | 30 |
| 2020 | 10 | 150 | 0 | 16 |
| 2021 | 5 | 107 | 0 | 10 |
| 2022 | 5 | 193 | 4 | 9 |
| 2023 | 6 | 190 | 1 | 20 |
| 2024 | 8 | 105 | 0 | 22 |
| 2025 | 6 | 29 | 0 | 9 |
| 2026 | 1 | — | 8 | — |
What is it indicated for?
The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1° C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO…
Read the full statement (346 words)
The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1° C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for validating this device for 134°C for 3.5 minutes with a 2 minute dry time.
VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles utilizing a biological indicator, integrating indicator or both a biological and integrating indicator from the following list.
. 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
. 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company
. Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc.
. Celerity 20 Steam Biological Indicator
. VERIFY STEAM Integrating Indicator
VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY STEAM Integrating Indicator.
The VERIFY All-In-One STEAM Resuable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Readout Biological Indicator catalog number 1292 can be used for routine monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Resuable Test Pack.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173633 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173633: VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173633
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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