510(k) · Cleared
ClearedViaduct Miniscope and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acueity, Inc. · GCT Light Source, Endoscope, Xenon Arc
Cleared on May 7, 2004 as substantially equivalent to K011189 (Acueity, Inc., 2001) and 1 other predicate after a 25-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- May 7, 2004
- Review
- 25 days
- Class
- Class II
- Product code
- GCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K926166 (1993). 8 ancestors in all, the oldest K910732 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK926166 Coast Video Endoscopic Imaging SystemOptik · 1993
- 2 generations backK983538 Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic…Solos Endoscopy, Inc. · 1998
- 1 generation backK983527 Microendoscope, Miniaturized Biopsy ScopeDofi Technologies, Inc. · 1999
- This deviceK040949 Viaduct Miniscope and AccessoriesAcueity, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K926166 | Coast Video Endoscopic Imaging System | Optik | 1993 | — |
| −2 | K983538 | Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic Viewing… | Solos Endoscopy, Inc. | 1998 | — |
| −1 | K983527 | Microendoscope, Miniaturized Biopsy Scope | Dofi Technologies, Inc. | 1999 | — |
| 0 (this device) | K040949 | Viaduct Miniscope and Accessories | Acueity, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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 GCT? 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K011189 | Viaduct Microendoscope and AccessoriesSummary page 2…y (formerly DOFI Communications, Inc.) Miniaturized Biopsy Scope and the Acueity ViaDuct Microendoscope and Accessories, cleared by the FDA under K011189 and K983527, respectively. The design of the ViaDuct Miniscope and Accessories is similar to the predicate device… | 2001 |
| * | K983527 | Microendoscope, Miniaturized Biopsy ScopeSummary page 2…ormerly DOFI Communications, Inc.) Miniaturized Biopsy Scope and the Acueity ViaDuct Microendoscope and Accessories, cleared by the FDA under K011189 and K983527, respectively. The design of the ViaDuct Miniscope and Accessories is similar to the predicate device insofar as… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- None of the 8 ancestors has a recall.
- 5 other devices also cite its predicate K011189.
How does its category compare?
All GCT devicesGCT Light Source, Endoscope, Xenon Arc: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCT
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · GCT
Too few GCT 510(k)s in any year since 2007 to give a median.
Recalls per year · GCT
No recall names GCT since 2007.
Adverse event reports per year · GCT
347in 2025
MAUDE reports naming product code GCT, 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 | 1 | — | 0 | 32 |
| 2008 | 1 | — | 0 | 29 |
| 2009 | 0 | — | 0 | 153 |
| 2010 | 1 | — | 0 | 21 |
| 2011 | 0 | — | 0 | 132 |
| 2012 | 0 | — | 0 | 36 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 20 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 0 | 149 |
| 2022 | 0 | — | 0 | 158 |
| 2023 | 0 | — | 0 | 200 |
| 2024 | 0 | — | 0 | 296 |
| 2025 | 0 | — | 0 | 347 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Acueity ViaDuct Miniscope and Accessories are intended for use by a physician for viewing an interior cavity of the human body through either a natural opening or an incision. The accessory device is capable of grasping soft tissue for biopsy. The instruments are to be used for diagnostic purposes only and are not intended for therapeutic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040949 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040949: Viaduct Miniscope and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040949
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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