510(k) · Cleared
ClearedCoast Video Endoscopic Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optik · FWF Camera, Television, Endoscopic, Without Audio
Cleared on Jun 1, 1993 after a 175-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jun 1, 1993
- Review
- 175 days
- Class
- Class I
- Product code
- FWF
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK926166 Coast Video Endoscopic Imaging SystemOptik · 1993
- Descendant · cites it directly · 5 of its ownK983538 Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic…Solos Endoscopy, Inc. · 1998
- Descendant · 2 generations on · 4 of its ownK983527 Microendoscope, Miniaturized Biopsy ScopeDofi Technologies, Inc. · 1999
- Descendant · 3 generations on · 2 of its ownK051073 Midiview Series of MicroendoscopesMillennium Devices, Inc. · 2006
- Descendant · 4 generations on · 0 of its ownK093785 Modular EndoscopeSialo Technology, Ltd. · 2010
- Descendant · 4 generations on · 0 of its ownK082735 Stone Grasping Basket, Model PD-T1 2115Sialo Technology, Ltd. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K983538Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic Viewing CapabilitySolos Endoscopy, Inc. · 1998 · cites it directly5descendants
- K983527Microendoscope, Miniaturized Biopsy ScopeDofi Technologies, Inc. · 1999 · 2 generations on4descendants
- K051073Midiview Series of MicroendoscopesMillennium Devices, Inc. · 2006 · 3 generations on2descendants
- K093785Modular EndoscopeSialo Technology, Ltd. · 2010 · 4 generations on0descendants
- K082735Stone Grasping Basket, Model PD-T1 2115Sialo Technology, Ltd. · 2009 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926166 | Coast Video Endoscopic Imaging System | Optik | 1993 | — |
| +1 | K983538 | Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic Viewing… | Solos Endoscopy, Inc. | 1998 | — |
| +2 | K983527 | Microendoscope, Miniaturized Biopsy Scope | Dofi Technologies, Inc. | 1999 | — |
| +3 | K051073 | Midiview Series of Microendoscopes | Millennium Devices, Inc. | 2006 | — |
| +4 | K093785 | Modular Endoscope | Sialo Technology, Ltd. | 2010 | — |
| +4 | K082735 | Stone Grasping Basket, Model PD-T1 2115 | Sialo Technology, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) 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 FWF? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983538 | Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic Viewing Capability | 1998 | 5 |
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, K983538 (Solos Endoscopy, Inc., 1998) has gone furthest, with 5 descendants of its own.
How does its category compare?
All FWF devicesFWF Camera, Television, Endoscopic, Without Audio: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FWF
FDA has decided no FWF device since 2007.
Median 510(k) review, days · FWF
Too few FWF 510(k)s in any year since 2007 to give a median.
Recalls per year · FWF
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FWF
27in 2025
MAUDE reports naming product code FWF, 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 | 0 | — | 2 | 1 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 28 |
| 2022 | 0 | — | 0 | 40 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 27 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K926166 · printed Nov 4, 2026
Cite this page
510(k) Report. “K926166: Coast Video Endoscopic Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K926166
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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