510(k) · Cleared
ClearedVerify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator
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 Nov 14, 2007 as substantially equivalent to K894399 (Pymah Corp., 1989) and 5 other predicates after a 128-day review. Its family tree reaches back 2 generations to 1980. 2 later devices descend from it.
- Decided
- Nov 14, 2007
- Review
- 128 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K801109 (1980). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK801109 Proof (Biological/Chemical Indicator)Amsco Co. · 1980
- 1 generation backK963841 EztestSgm Biotech, Inc. · 1997 · Recalled
- This deviceK071895 Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007
- Descendant · cites it directly · 0 of its ownK162758 VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators…STERIS Corporation · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK102894 Classix Chemical Sterilization IndicatorPropper Mfg. Co., Inc. · 2011
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 |
|---|---|---|---|---|---|
| −2 | K801109 | Proof (Biological/Chemical Indicator) | Amsco Co. | 1980 | — |
| −1 | K963841 | Eztest | Sgm Biotech, Inc. | 1997 | 1 |
| 0 (this device) | K071895 | Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator | STERIS Corporation | 2007 | — |
| +1 | K162758 | VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie… | STERIS Corporation | 2017 | 1 |
| +1 | K102894 | Classix Chemical Sterilization Indicator | Propper Mfg. Co., Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K894399 | Sterigage Integrator Test Pack for Steam Sterili.Summary page 2…dicator (21 CFR 880.2800 (b), Product Code JOJ). 2. Predicate Devices * 3M SteriGage Chemical Indicators (K894399) * DANA SteriScan Indicators (1(012195) * StcriTec Integraph (Cardinal Steam Integrators1 ) (K960441)… | 1989 |
| * | K012195 | Steam Sterilization IntergratorSummary page 2…CFR 880.2800 (b), Product Code JOJ). 2. Predicate Devices * 3M SteriGage Chemical Indicators (K894399) * DANA SteriScan Indicators (1(012195) * StcriTec Integraph (Cardinal Steam Integrators1 ) (K960441) STERIS Verify Integrators (K902958, K0… | 2002 |
| * | K960441 | Steritec Integraph Model CI-101Summary page 2…* 3M SteriGage Chemical Indicators (K894399) * DANA SteriScan Indicators (1(012195) * StcriTec Integraph (Cardinal Steam Integrators1 ) (K960441) STERIS Verify Integrators (K902958, K002937) * EZ Test Steam Biological Indicator (K963841) 3.… | 1997 |
| * | K902958 | TST Control Integrator for Steam AutoclaveSummary page 2…* DANA SteriScan Indicators (1(012195) * StcriTec Integraph (Cardinal Steam Integrators1 ) (K960441) STERIS Verify Integrators (K902958, K002937) * EZ Test Steam Biological Indicator (K963841) 3. Device Description The proposed Verify' 275F… | 1990 |
| * | K002937 | TST Control Integrator for Steam SterilizersSummary page 2…* DANA SteriScan Indicators (1(012195) * StcriTec Integraph (Cardinal Steam Integrators1 ) (K960441) STERIS Verify Integrators (K902958, K002937) * EZ Test Steam Biological Indicator (K963841) 3. Device Description The proposed Verify' 275F 3 Indica… | 2001 |
| * | K963841 | EztestSummary page 2…tcriTec Integraph (Cardinal Steam Integrators1 ) (K960441) STERIS Verify Integrators (K902958, K002937) * EZ Test Steam Biological Indicator (K963841) 3. Device Description The proposed Verify' 275F 3 Indicator consist of: * A 22 mm x 143 mm polypropyle… | 1997 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 16.7 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K162758 (STERIS Corporation, 2017) has gone furthest, with 0 descendants of its own.
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. 2007, 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 3 Indicator is a chemical indicator intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The Verify® 275F 3 Indicator is an emulating indicator intended for use in steam sterilization. The indicator changes color from yellow to blue/purple when exposed to 275°F (135°C) pre-vacuum sterilization cycles for 3 minutes as indicated in the following table:
MODEL: Verify 275F 3; TEMPERATURE: 275°F (135°C); STERILIZATION TYPE: Pre-vacuum steam; TIME: 3 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071895 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071895: Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071895
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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