510(k) Report

510(k) · Cleared

Cleared

Camera Enabled Probe

K141119510(k) TraditionalCleared Jul 29, 201490-day reviewClass II21 CFR 888.1100

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

Trice Medical, Inc. · HRX Arthroscope

Cleared on Jul 29, 2014 as substantially equivalent to K093717 (Axis Surgical Technologies, Inc., 2010) after a 90-day review. Its family tree reaches back 7 generations to 1983. 7 later devices descend from it.

Decided
Jul 29, 2014
Review
90 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K833587 (1983). 24 ancestors in all, the oldest K771218 (1978). 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor1992: 2 other ancestors2001: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors1994: 2 other ancestors1991: 1 other ancestor1990: 1 other ancestor1988: 1 other ancestor1982: 1 other ancestor1978: 1 other ancestor2016: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2024: 2 descendants cleared2021: 1 descendant cleared2026: 1 descendant clearedK833587 · Disposable Arthroscopy Blade · Dyonics, Inc. · 1983K900070 · Modified Uses of the Arthroscopic Surgical System · Dyonics, Inc. · 1990K971253 · Various Arthroscopes, Endoscopic Blades, Manual Instruments · Smith & Nephew, Inc. · 1997K043395 · Smith & Nephew Videoarthroscope · Smith & Nephew, Inc. · 2005K072879 · Innervue Diagnostic Scope System · Biomet Orthopedics, Inc. · 2008 · recalledK082293 · Surgview Integrated Visualization System · Biovision Technologies, LLC · 2008K093717 · C-Mor Visualization Device · Axis Surgical Technologies, Inc. · 201019801990200020102020
  1. Root · 7 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
  2. 6 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
  3. 5 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
  4. 4 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
  5. 3 generations backK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
  6. 2 generations backK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
  7. 1 generation backK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
  8. This deviceK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014
  9. Descendant · cites it directly · 6 of its ownK162475 mi-eye 2, mi-eye 2 monitorTrice Medical · 2016
  10. Descendant · 2 generations on · 2 of its ownK181982 MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc. · 2018
  11. Descendant · 3 generations on · 1 of its ownK243020 MIDASVuIntravu, Inc. · 2024
  12. Descendant · 4 generations on · 0 of its ownK252579 Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026
  13. Descendant · 2 generations on · 0 of its ownK233115 Hawkeye Control Unit with Eyas EndoscopeE Surgical, LLC · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2016: 12018: 12019: 12021: 12024: 22026: 1
2016high 2 (2024) · low 0 (2017)2026

Most influential descendants

Showing 5 of 7 · See all
  • K162475mi-eye 2, mi-eye 2 monitorTrice Medical · 2016 · cites it directly6descendants
  • K181982MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc. · 2018 · 2 generations on2descendants
  • K243020MIDASVuIntravu, Inc. · 2024 · 3 generations on1descendant
  • K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026 · 4 generations on0descendants
  • K233115Hawkeye Control Unit with Eyas EndoscopeE Surgical, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K833587Disposable Arthroscopy BladeDyonics, Inc.1983—
−6K900070Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc.1990—
−5K971253Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc.1997—
−4K043395Smith & Nephew VideoarthroscopeSmith & Nephew, Inc.2005—
−3K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc.20082
−2K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC2008—
−1K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc.2010—
0 (this device)K141119Camera Enabled ProbeTrice Medical, Inc.2014—
+1K162475mi-eye 2, mi-eye 2 monitorTrice Medical2016—
+2K181982MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc.2018—
+3K243020MIDASVuIntravu, Inc.2024—
+4K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.2026—
+2K233115Hawkeye Control Unit with Eyas EndoscopeE Surgical, LLC2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198210
198810
199010
199110
199220
199420
199520
199610
200010
200110
200210
200310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201810
201910
202110
202420
202610
FIG. 1 — Lineage of K141119, 1983–2026Source: 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 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? (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
*K093717C-Mor Visualization Device
Summary page 1
…1 Product Code: HRX, 888.1100 Predicate Device(s): The subject device is equivalent to the following devices: * K093717 - C-MOR Visualization System Device Description: The Camera Enabled Probe is a battery operated, portable,…
Axis Surgical Technologies, Inc.2010—

Also cleared against K093717: 1 other device →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K162475mi-eye 2, mi-eye 2 monitorTrice Medical20166

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 31 years and passes through 6 companies; a new generation was cleared every 4.4 years on median.
  • 2 of the 24 ancestors have a recall of any class.
  • Of its descendants, K162475 (Trice Medical, 2016) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K093717.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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—

What is it indicated for?

The Camera Enabled Probe is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K141119: Camera Enabled Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141119

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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