510(k) · Cleared
ClearedDavlite Microendoscope & Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davlite Technologies · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 20, 2002 as substantially equivalent to K011189 (Acueity, Inc., 2001) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 1994. 37 later devices descend from it.
- Decided
- Mar 20, 2002
- Review
- 50 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932987 (1994). 2 ancestors in all. 37 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK932987 Birtcher Laparoscope and AccessoriesBirtcher Medical Systems, Inc. · 1994
- This deviceK020310 Davlite Microendoscope & AccessoriesDavlite Technologies · 2002
- Descendant · cites it directly · 31 of its ownK040604 Innervue Diagnostic Scope SystemArthrotek, Inc. · 2004
- Descendant · 2 generations on · 30 of its ownK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
- Descendant · cites it directly · 21 of its ownK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
- Descendant · 2 generations on · 16 of its ownK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
- Descendant · 3 generations on · 7 of its ownK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K040604Innervue Diagnostic Scope SystemArthrotek, Inc. · 2004 · cites it directly31descendants
- K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · 2 generations on30descendants
- K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008 · cites it directly21descendants
- K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010 · 2 generations on16descendants
- K141119Camera Enabled ProbeTrice Medical, Inc. · 2014 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932987 | Birtcher Laparoscope and Accessories | Birtcher Medical Systems, Inc. | 1994 | — |
| 0 (this device) | K020310 | Davlite Microendoscope & Accessories | Davlite Technologies | 2002 | — |
| +1 | K040604 | Innervue Diagnostic Scope System | Arthrotek, Inc. | 2004 | — |
| +2 | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | 2 |
| +1 | K082293 | Surgview Integrated Visualization System | Biovision Technologies, LLC | 2008 | — |
| +2 | K093717 | C-Mor Visualization Device | Axis Surgical Technologies, Inc. | 2010 | — |
| +3 | K141119 | Camera Enabled Probe | Trice Medical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 1…ed on similarities of intended use, design, and materials, physical characteristics and geometry between the Daviite Microendoscope and Acueity Microendoscope (Viaduct) (K011189) and Solos Endoscope (K932987) among other marketed visualization products. ©) ERVIC, N SERICEs, “ %, PO N %… | 2001 |
| * | K932987 | Birtcher Laparoscope and AccessoriesSummary page 1…use, design, and materials, physical characteristics and geometry between the Daviite Microendoscope and Acueity Microendoscope (Viaduct) (K011189) and Solos Endoscope (K932987) among other marketed visualization products. ©) ERVIC, N SERICEs, “ %, PO N % ¥, @ DEPARTMENT OF HEALTH & H… | 1994 |
What descends from it? (37)
See all 375 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?
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or an incision.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020310: Davlite Microendoscope & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020310
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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