De Novo · Granted
GrantedSystem 1E Process Biological Monitoring Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · OVY Liquid Chemical Processing System
Granted on Mar 30, 2012 as a new device type through De Novo after a 242-day review. 22 later devices descend from it.
- Decided
- Mar 30, 2012
- Review
- 242 days
- Class
- Class II
- Product code
- OVY
- Recalls
- None
22 later devices descend from it, 2 citing it directly.
- This deviceDEN110002 System 1E Process Biological Monitoring KitSTERIS Corporation · 2012
- Descendant · cites it directly · 18 of its ownK122509 Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012
- Descendant · 2 generations on · 12 of its ownK132968 Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013
- Descendant · 3 generations on · 9 of its ownK140046 Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015
- Descendant · 4 generations on · 8 of its ownK151741 HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015
- Descendant · 5 generations on · 7 of its ownK163428 HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012 · cites it directly18descendants
- K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013 · 2 generations on12descendants
- K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015 · 3 generations on9descendants
- K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015 · 4 generations on8descendants
- K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN110002 | System 1E Process Biological Monitoring Kit | STERIS Corporation | 2012 | — |
| +1 | K122509 | Vertiflex Spinous Process Fixation Plate | Vertiflex, Inc. | 2012 | — |
| +2 | K132968 | Univise Spinous Process Fixation Plate (35MM, 40MM) | Stryker Spine | 2013 | — |
| +3 | K140046 | Spinous Process Fusion (SPF) Plate | Spinal Simplicity, LLC | 2015 | — |
| +4 | K151741 | HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | 2015 | — |
| +5 | K163428 | HA Minuteman G3-R MIS Fusion Plate | Spinal Simplicity | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OVY? 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 OVY device
- #1 K231746 VERIFY Spore Test Strip for S40 Sterilant…score 9.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (22)
See all 222 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?
- Of its descendants, K122509 (Vertiflex, Inc., 2012) has gone furthest, with 18 descendants of its own.
How does its category compare?
All OVY devicesOVY Liquid Chemical Processing System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OVY
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OVY
Too few OVY 510(k)s in any year since 2007 to give a median.
Recalls per year · OVY
No recall names OVY since 2007.
Adverse event reports per year · OVY
No MAUDE report names OVY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN110002 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN110002: System 1E Process Biological Monitoring Kit.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN110002
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026