510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Integrated Endoscopy System 1000

K920800510(k) TraditionalCleared Jun 30, 1992130-day reviewClass II21 CFR 888.1100Recalls 1

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

Biomet, Inc. · HRX Arthroscope

Cleared on Jun 30, 1992 after a 130-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 32 later devices descend from it. It has been recalled once.

Decided
Jun 30, 1992
Review
130 days
Class
Class II
Product code
HRX
Recalls
1
Predicates
0

32 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2008: 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 cleared1990200020102020
  1. This deviceK920800 Integrated Endoscopy System 1000Biomet, Inc. · 1992
  2. Descendant · cites it directly · 30 of its ownK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
  3. Descendant · 2 generations on · 21 of its ownK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
  4. Descendant · 2 generations on · 16 of its ownK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
  5. Descendant · 3 generations on · 7 of its ownK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014
  6. 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 32 descendants. See all descendants

Descendants cleared per year

2002: 12008: 22010: 22011: 12012: 22014: 22015: 42016: 22017: 12018: 22019: 32020: 12021: 32022: 22024: 22026: 2
2002high 4 (2015) · low 0 (2003)2026

Most influential descendants

Showing 5 of 32 · 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
0 (this device)K920800Integrated Endoscopy System 1000Biomet, Inc.1992—
+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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200820
201020
201110
201220
201420
201540
201620
201710
201820
201930
202010
202130
202220
202420
202620
FIG. 1 — Lineage of K920800, 1992–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HRX? 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 HRX device

  1. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (32)

See all 32

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc.200830
K020761Power Tek IIBiomet, Inc.20020

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 1, 2016Class IIZ-1818-2016Equipment maintenanceInsufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K072879 (Biomet Orthopedics, Inc., 2008) has gone furthest, with 30 descendants of its own.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

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

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, 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
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

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  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

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The HRX category page

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https://510kreport.com/device/K920800 · printed Nov 4, 2026

Cite this page

510(k) Report. “K920800: Integrated Endoscopy System 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K920800

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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