De Novo · Granted
GrantedNOVA View Automated Fluorescense Microscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · PIV Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
Granted on Apr 9, 2015 as a new device type through De Novo after a 115-day review. 1 later device descends from it.
- Decided
- Apr 9, 2015
- Review
- 115 days
- Class
- Class II
- Product code
- PIV
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN140039 NOVA View Automated Fluorescense MicroscopeInova Diagnostics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK153150 AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000Inova Diagnostics, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K153150AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000Inova Diagnostics, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN140039 | NOVA View Automated Fluorescense Microscope | Inova Diagnostics, Inc. | 2015 | — |
| +1 | K153150 | AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 | Inova Diagnostics, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
Sources: FDA De Novo 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 PIV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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 |
|---|---|---|---|
| K153150 | AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 | 2015 | 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?
- Of its descendants, K153150 (Inova Diagnostics, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PIV devicesPIV Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PIV
2in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · PIV
Too few PIV 510(k)s in any year since 2007 to give a median.
Recalls per year · PIV
No recall names PIV since 2007.
Adverse event reports per year · PIV
No MAUDE report names PIV 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
NOVA View® Automated Fluorescence Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescence technology. The device can only be used with cleared or approved in vitro diagnostic assays that are indicated for use with the device. A trained operator must confirm results generated with the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN140039 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN140039: NOVA View Automated Fluorescense Microscope.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN140039
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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