510(k) Report

510(k) · Cleared

Cleared

Vitlite (TR7700)

K963417510(k) TraditionalCleared Dec 20, 1996112-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

Escalon Trek Medical · MPA Endoilluminator

Cleared on Dec 20, 1996 after a 112-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Dec 20, 1996
Review
112 days
Class
Class II
Product code
MPA
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 2 descendants cleared2006: 2 descendants cleared1995200020052010201520202025
  1. This deviceK963417 Vitlite (TR7700)Escalon Trek Medical · 1996
  2. Descendant · cites it directly · 2 of its ownK973229 D.O.R.C. Hexon Illumination SystemDutch Ophthalmic USA, Inc. · 1997
  3. Descendant · 2 generations on · 0 of its ownK062895 Xenon Brightstar Illumination System, Model 1266.XiiiDutch Ophthalmic Research Center International BV · 2006
  4. Descendant · 2 generations on · 0 of its ownK062259 Iscience Surgical Fiberoptic Illuminator, Model FI - 100Iscience Surgical · 2006
  5. Descendant · cites it directly · 0 of its ownK973757 D.O.R.C. Solux Light SourceDutch Ophthalmic USA, Inc. · 1997

Most influential descendants

Showing 4 of 4 · See all
  • K973229D.O.R.C. Hexon Illumination SystemDutch Ophthalmic USA, Inc. · 1997 · cites it directly2descendants
  • K062895Xenon Brightstar Illumination System, Model 1266.XiiiDutch Ophthalmic Research Center International BV · 2006 · 2 generations on0descendants
  • K062259Iscience Surgical Fiberoptic Illuminator, Model FI - 100Iscience Surgical · 2006 · 2 generations on0descendants
  • K973757D.O.R.C. Solux Light SourceDutch Ophthalmic USA, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K963417Vitlite (TR7700)Escalon Trek Medical1996—
+1K973229D.O.R.C. Hexon Illumination SystemDutch Ophthalmic USA, Inc.1997—
+2K062895Xenon Brightstar Illumination System, Model 1266.XiiiDutch Ophthalmic Research Center International BV2006—
+2K062259Iscience Surgical Fiberoptic Illuminator, Model FI - 100Iscience Surgical2006—
+1K973757D.O.R.C. Solux Light SourceDutch Ophthalmic USA, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
200620
FIG. 1 — Lineage of K963417, 1996–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 MPA? 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 MPA device

  1. #1 K253468 Nova Eye iTrack™ 250A Canaloplasty…score 12.7 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (4)

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

NumberDeviceApplicantDecidedDescendants
K973229D.O.R.C. Hexon Illumination SystemDutch Ophthalmic USA, Inc.19972
K973757D.O.R.C. Solux Light SourceDutch Ophthalmic USA, Inc.19970

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?

  • Of its descendants, K973229 (Dutch Ophthalmic USA, Inc., 1997) has gone furthest, with 2 descendants of its own.

How does its category compare?

All MPA devices

MPA Endoilluminator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MPA

2in 2024

2008: 12015: 22021: 12023: 12024: 22026 (partial year): 1
2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MPA

Too few MPA 510(k)s in any year since 2007 to give a median.

Recalls per year · MPA

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

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

Adverse event reports per year · MPA

11in 2025

2007: 42008: 102009: 42010: 392011: 322012: 352013: 192014: 102015: 42016: 22017: 22018: 42022: 32023: 82024: 622025: 11
2007high 62 (2024) · low 0 (2019)2025

MAUDE reports naming product code MPA, 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
20070—04
20081—010
20090—04
20100—039
20110—032
20120—035
20130—019
20140—010
20152—04
20160—02
20170—02
20180—04
20190—00
20200—00
20211—00
20220—03
20231—08
20242—062
20250—111
20261—0—

More from Escalon Trek Medical

3 FDA decisions under this applicant name. See the company

  • K963434Viscous Fluid SystemEscalon Trek Medical · 1996
  • K924999Autopole Regulator SystemEscalon Trek Medical · 1992

Recent decisions in MPA

The MPA category page

  • K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc. · 2026
  • K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS…Alcon Laboratories, Inc. · 20242 recalls
  • K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga…Peregrine Surgical, LLC · 2024
  • K221872ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemNova Eye Inc. (Business Name Nova Eye Medical) · 2023
  • K202670Nam illumination probe with chopperOculight, Ltd. · 2021

https://510kreport.com/device/K963417 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963417: Vitlite (TR7700).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963417

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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