510(k) · Cleared
ClearedMidiview Series of Microendoscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Millennium Devices, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 17, 2006 as substantially equivalent to K983527 (Dofi Technologies, Inc., 1999) and 4 other predicates after a 386-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- May 17, 2006
- Review
- 386 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K926166 (1993). 12 ancestors in all, the oldest K910732 (1991). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK051073 Midiview Series of MicroendoscopesMillennium Devices, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK093785 Modular EndoscopeSialo Technology, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK082735 Stone Grasping Basket, Model PD-T1 2115Sialo Technology, Ltd. · 2009
Most influential descendants
Showing 2 of 2 · See allView 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) | K051073 | Midiview Series of Microendoscopes | Millennium Devices, Inc. | 2006 | — |
| +1 | K093785 | Modular Endoscope | Sialo Technology, Ltd. | 2010 | — |
| +1 | K082735 | Stone Grasping Basket, Model PD-T1 2115 | Sialo Technology, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 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? (5)
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 |
|---|---|---|---|
| * | K983527 | Microendoscope, Miniaturized Biopsy ScopeSummary page 1…es. A small cross section of predicates is included in this submission for review. DOFI Communications Inc. Miniature Endo/Laparoscope and accessories, (K983527) Acueity In.c. ViaDuct Micro endoscope and Accessories (KO I1189) Karl Storz Inc. Sialoendoscope and accessories… | 1999 |
| * | K011189 | Viaduct Microendoscope and AccessoriesSummary page 2…evices mentioned, such as DOFI Communications Inc. Miniature Endo/Laparoscope and accessories, (K983527) Acueity In.c. ViaDuct Micro endoscope and Accessories (K011189) Karl Storz Inc. Sialoendoscope and accessories (K012527), Davlite Technologies Davlite Micro Endoscope and Accessories… | 2001 |
| * | K012527 | Ksea Sialoendoscopes and AccessoriesSummary page 1…o/Laparoscope and accessories, (K983527) Acueity In.c. ViaDuct Micro endoscope and Accessories (KO I1189) Karl Storz Inc. Sialoendoscope and accessories (K012527) Davlite Technologies Davlite Micro Endoscope and Accessories (K0203 10). Akermann Instrumente Laparoscopes and A… | 2001 |
| * | K020310 | Davlite Microendoscope & AccessoriesSummary page 1…doscope and Accessories (KO I1189) Karl Storz Inc. Sialoendoscope and accessories (K012527) Davlite Technologies Davlite Micro Endoscope and Accessories (K0203 10). Akermann Instrumente Laparoscopes and Accessories (K974382) 4. Device Description The Millennium Devices Inc. MDI… | 2002 |
| * | K974382 | Ackermann Surgical InstrumentsSummary page 1…ope and accessories (K012527) Davlite Technologies Davlite Micro Endoscope and Accessories (K0203 10). Akermann Instrumente Laparoscopes and Accessories (K974382) 4. Device Description The Millennium Devices Inc. MDI-View MicroFibre Endoscope Series and Accessories are fiber optic bas… | 1998 |
What descends from it? (2)
2 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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K093785 (Sialo Technology, Ltd., 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K983527.
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?
The Arthroview is intended for use in providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures The Microview Series of Microendosocopes are intended for use in providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures The Sialoview series of microendoscopes are for use by qualified surgeons…
Read the full statement (116 words)
The Arthroview is intended for use in providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures
The Microview Series of Microendosocopes are intended for use in providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures
The Sialoview series of microendoscopes are for use by qualified surgeons for the diagnosis and treatment of salivary gland diseases. The Sialoview scopes are used to visualize the surgical site in salivary gland diagnosis and therapeutic procedures.
The Sinoview is intended for use in providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051073: Midiview Series of Microendoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051073
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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