510(k) Report

510(k) · Cleared

Cleared

Iscience Surgical Ophthalmic Microcannula

K041108510(k) TraditionalCleared Jun 22, 200455-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

Iscience Surgical Corporation · MPA Endoilluminator

Cleared on Jun 22, 2004 as substantially equivalent to K970882 (American Medical Devices, Inc., 1997) and 2 other predicates after a 55-day review. Its family tree reaches back 2 generations to 1988. 10 later devices descend from it.

Decided
Jun 22, 2004
Review
55 days
Class
Class II
Product code
MPA
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K884043 (1988). 4 ancestors in all. 10 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1997: 1 other ancestor2008: 1 descendant cleared2023: 2 descendants cleared2017: 1 descendant cleared2026: 2 descendants cleared2020: 1 descendant cleared2021: 2 descendants cleared2025: 1 descendant clearedK884043 · Grieshaber Micro Lite Light Pipe 19 & 20 Gauge · Grieshaber & Co. · 1988K973293 · Syntec True Light End Irrigating Endoilluminator · Vaughan Weeks · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K973293 · Syntec True Light End Irrigating Endoilluminator · Vaughan Weeks · 1997K884043 · Grieshaber Micro Lite Light Pipe 19 & 20 Gauge · Grieshaber & Co. · 19880+5
  1. Root · 2 generations backK884043 Grieshaber Micro Lite Light Pipe 19 & 20 GaugeGrieshaber & Co. · 1988
  2. 1 generation backK973293 Syntec True Light End Irrigating EndoilluminatorVaughan Weeks · 1997
  3. This deviceK041108 Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation · 2004
  4. Descendant · cites it directly · 9 of its ownK080067 Iscience Interventional Ophthalmic MicrocatheterIscience Interventional · 2008 · Recalled
  5. Descendant · 2 generations on · 6 of its ownK173332 OMNI Surgical SystemSight Sciences, Inc. · 2017
  6. Descendant · 3 generations on · 2 of its ownK202678 OMNI Surgical SystemSight Sciences, Inc. · 2021
  7. Descendant · 4 generations on · 1 of its ownK232214 OMNI Surgical SystemSight Sciences, Inc. · 2023
  8. Descendant · 2 generations on · 0 of its ownK253468 Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc. · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2008: 12017: 12020: 12021: 22023: 22025: 12026: 2
2008high 2 (2021) · low 0 (2009)2026

Most influential descendants

Showing 5 of 10 · See all
  • K080067Iscience Interventional Ophthalmic MicrocatheterIscience Interventional · 2008 · cites it directly9descendants
  • K173332OMNI Surgical SystemSight Sciences, Inc. · 2017 · 2 generations on6descendants
  • K202678OMNI Surgical SystemSight Sciences, Inc. · 2021 · 3 generations on2descendants
  • K232214OMNI Surgical SystemSight Sciences, Inc. · 2023 · 4 generations on1descendant
  • K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K884043Grieshaber Micro Lite Light Pipe 19 & 20 GaugeGrieshaber & Co.1988—
−1K973293Syntec True Light End Irrigating EndoilluminatorVaughan Weeks1997—
0 (this device)K041108Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation2004—
+1K080067Iscience Interventional Ophthalmic MicrocatheterIscience Interventional20082
+2K173332OMNI Surgical SystemSight Sciences, Inc.2017—
+3K202678OMNI Surgical SystemSight Sciences, Inc.2021—
+4K232214OMNI Surgical SystemSight Sciences, Inc.2023—
+2K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201710
202010
202120
202320
202510
202620
FIG. 1 — Lineage of K041108, 1988–2026Source: 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), 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 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? (3)

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
*K970882Endolight End Irrigating Endo-Illuminator (20 GA. and 19 GA.)
Summary page 1
…e devices: Company: American Medical Devices, Inc Device: Endolight End Irrigating Endoilluminator 51 0(k): K970882 Company: Syntec, Inc. Device: True Light End Irrigating Endoillumninator 51 0(…
American Medical Devices, Inc.1997—
*K973293Syntec True Light End Irrigating Endoilluminator
Summary page 1
…0(k): K970882 Company: Syntec, Inc. Device: True Light End Irrigating Endoillumninator 51 0(k): K973293 Company: Micron Surgical, Inc. Device: Weiss Retinal Cannula 510(k):…
Vaughan Weeks1997—
*K010305Weiss Retinal Cannula
Summary page 1
…51 0(k): K973293 Company: Micron Surgical, Inc. Device: Weiss Retinal Cannula 510(k): K010305 ISCIENCE SURGICAL CORPORATION PREMARKET NOTIFICATION - OPHTHALMIC MICROCANNULA 0…
Micron Surgical, Inc.2001—

Also cleared against K970882: 2 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K080067Iscience Interventional Ophthalmic MicrocatheterIscience Interventional20089

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 16 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K080067 (Iscience Interventional, 2008) has gone furthest, with 9 descendants of its own.
  • 2 other devices also cite its predicate K970882.

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—

What is it indicated for?

The iScience Surgical Ophthalmic Microcannula is indicated for fluid infusion and aspiration, with illumination, during surgery.

Indications for use as stated in the FDA summary.

Also cleared against K970882

2 other devices cite the same predicate.

  • K080067Iscience Interventional Ophthalmic MicrocatheterIscience Interventional · 20082 recalls
  • K991323Smith & Nephew Subcutaneous IlluminatorSmith & Nephew, Inc. · 1999

More from Iscience Surgical Corporation

2 FDA decisions under this applicant name. See the company

  • K050716Iscience Surgical ViscoinjectorIscience Surgical Corporation · 2005

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/K041108 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041108: Iscience Surgical Ophthalmic Microcannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041108

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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