510(k) Report

510(k) · Cleared

Cleared

Innervue Diagnostic Scope System

K040604510(k) TraditionalCleared Jun 4, 200488-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arthrotek, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jun 4, 2004 as substantially equivalent to K020310 (Davlite Technologies, 2002) after an 88-day review. Its family tree reaches back 2 generations to 1994. 31 later devices descend from it.

Decided
Jun 4, 2004
Review
88 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K932987 (1994). 3 ancestors in all. 31 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2008: 2 descendants cleared2012: 2 descendants cleared2011: 1 descendant cleared2010: 2 descendants cleared2015: 4 descendants cleared2014: 2 descendants cleared2016: 2 descendants cleared2018: 2 descendants cleared2021: 3 descendants cleared2026: 2 descendants cleared2017: 1 descendant cleared2019: 3 descendants cleared2024: 2 descendants cleared2020: 1 descendant cleared2022: 2 descendants clearedK932987 · Birtcher Laparoscope and Accessories · Birtcher Medical Systems, Inc. · 1994K020310 · Davlite Microendoscope & Accessories · Davlite Technologies · 20021990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 9 descendants4 generations forward: 7 descendants5 generations forward: 6 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K020310 · Davlite Microendoscope & Accessories · Davlite Technologies · 2002K932987 · Birtcher Laparoscope and Accessories · Birtcher Medical Systems, Inc. · 19940+5
  1. Root · 2 generations backK932987 Birtcher Laparoscope and AccessoriesBirtcher Medical Systems, Inc. · 1994
  2. 1 generation backK020310 Davlite Microendoscope & AccessoriesDavlite Technologies · 2002
  3. This deviceK040604 Innervue Diagnostic Scope SystemArthrotek, Inc. · 2004
  4. Descendant · cites it directly · 30 of its ownK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
  5. Descendant · 2 generations on · 21 of its ownK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
  6. Descendant · 2 generations on · 16 of its ownK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
  7. Descendant · 3 generations on · 7 of its ownK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014
  8. Descendant · 2 generations on · 7 of its ownK102733 Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…Vision-Sciences, Inc. · 2011

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2008: 22010: 22011: 12012: 22014: 22015: 42016: 22017: 12018: 22019: 32020: 12021: 32022: 22024: 22026: 2
2008high 4 (2015) · low 0 (2009)2026

Most influential descendants

Showing 5 of 31 · See all
  • K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · cites it directly30descendants
  • K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008 · 2 generations on21descendants
  • K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010 · 2 generations on16descendants
  • K141119Camera Enabled ProbeTrice Medical, Inc. · 2014 · 3 generations on7descendants
  • K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc. · 2011 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K932987Birtcher Laparoscope and AccessoriesBirtcher Medical Systems, Inc.1994—
−1K020310Davlite Microendoscope & AccessoriesDavlite Technologies2002—
0 (this device)K040604Innervue Diagnostic Scope SystemArthrotek, Inc.2004—
+1K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc.20082
+2K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC2008—
+2K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc.2010—
+3K141119Camera Enabled ProbeTrice Medical, Inc.2014—
+2K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…Vision-Sciences, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201020
201110
201220
201420
201540
201620
201710
201820
201930
202010
202130
202220
202420
202620
FIG. 1 — Lineage of K040604, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K020310Davlite Microendoscope & Accessories
Summary page 1
…doscope Classification Name: Endoscope Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Davlite Microendoscope, K020310 Device Description: The InnerVueTM Diagnostic Scope System consists of 5 main parts; the hardware, the software, the scope, the…
Davlite Technologies2002—

Also cleared against K020310: 4 other devices →

What descends from it? (31)

See all 31

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc.200830

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 10 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K072879 (Biomet Orthopedics, Inc., 2008) has gone furthest, with 30 descendants of its own.
  • 4 other devices also cite its predicate K020310.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

What is it indicated for?

This device is to be used by a trained physician for viewing the interior cavity of the human body through either a surgical or natural opening.

Indications for use as stated in the FDA summary.

Also cleared against K020310

4 other devices cite the same predicate.

  • K091600Directvision Guide SystemPercuvision, LLC · 2009
  • K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
  • K051073Midiview Series of MicroendoscopesMillennium Devices, Inc. · 2006
  • K050650Novacyte Microendoscope and Accessories, Models NC1000;NCAM1000Cytyc Surgical Products · 2005

More from Arthrotek, Inc.

17 FDA decisions under this applicant name. See the company

  • K061776Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc. · 2006
  • K0618012.8 & 3.5MM Lactoscrew Suture AnchorsArthrotek, Inc. · 2006
  • K061657Hitch Lactosorb Suture AnchorArthrotek, Inc. · 2006
  • K061389Allthread Lactosorb Suture AnchorArthrotek, Inc. · 2006
  • K060693Microstrike and Allthread Peek Suture AnchorArthrotek, Inc. · 2006

Recent decisions in GCJ

The GCJ category page

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https://510kreport.com/device/K040604 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040604: Innervue Diagnostic Scope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040604

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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