510(k) · Cleared
ClearedVerify 275F Gravity Indicators
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 Aug 7, 2009 as substantially equivalent to K012195 (Dana Products, Inc., 2002) and 2 other predicates after a 241-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Aug 7, 2009
- Review
- 241 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K960441 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK960441 Steritec Integraph Model CI-101Steritec Products Mfg Co, Inc. · 1997
- This deviceK083643 Verify 275F Gravity IndicatorsSTERIS Corporation · 2009
- 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 |
|---|---|---|---|---|---|
| −1 | K960441 | Steritec Integraph Model CI-101 | Steritec Products Mfg Co, Inc. | 1997 | — |
| 0 (this device) | K083643 | Verify 275F Gravity Indicators | STERIS Corporation | 2009 | — |
| +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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 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? (3)
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 |
|---|---|---|---|
| * | K012195 | Steam Sterilization IntergratorSummary page 2…rocess indicators (21 CFR 880.2800 (b), Product Code JOJ). 2. Predicate Devices · DANA SteriScan Indicators (K012195) · SteriTec Integraph [Cardinal Steam Integrators' (K96044 1)] · STERIS Verify Integrators (K002937) 3.… | 2002 |
| * | K960441 | Steritec Integraph Model CI-101Summary page 2…0.2800 (b), Product Code JOJ). 2. Predicate Devices · DANA SteriScan Indicators (K012195) · SteriTec Integraph [Cardinal Steam Integrators' (K96044 1)] · STERIS Verify Integrators (K002937) 3. Device Description The proposed Verify® 275F Gravity Indicators… | 1997 |
| * | K002937 | TST Control Integrator for Steam SterilizersSummary page 2…ces · DANA SteriScan Indicators (K012195) · SteriTec Integraph [Cardinal Steam Integrators' (K96044 1)] · STERIS Verify Integrators (K002937) 3. Device Description The proposed Verify® 275F Gravity Indicators consist of: • A 22 mm x 143 mm polypr… | 2001 |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2009, 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® 275F Gravity Indicators are chemical integrators which meet ANSI/AAMI 1140-1:2005 for emulating indicators intended for use in steam sterilization. The Verify® 275F.Gravity Indicators change color from yellow to blue/purple when exposed to 275°F (135°C) and to the appropriate cycle type and duration. The Verify® 275F Indicators models and their cycle types and times are:
MODEL TEMPERATURE STERILIZATION TYPE TIME
Verify 275F 3-10 275°F (135°C) Gravity flash steam 3 and 10 minutes
Verify 275F 10 275°F (135°C) Gravity steam 10 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083643: Verify 275F Gravity Indicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083643
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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