510(k) Report

510(k) · Cleared

Cleared

Weiss Retinal Cannula

K010305510(k) TraditionalCleared May 2, 200190-day reviewClass I21 CFR 886.4350

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

Micron Surgical, Inc. · HMX Cannula, Ophthalmic

Cleared on May 2, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided
May 2, 2001
Review
90 days
Class
Class I
Product code
HMX
Recalls
None
Predicates
0

11 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2008: 1 descendant cleared2023: 2 descendants cleared2017: 1 descendant cleared2026: 2 descendants cleared2020: 1 descendant cleared2021: 2 descendants cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK010305 Weiss Retinal CannulaMicron Surgical, Inc. · 2001
  2. Descendant · cites it directly · 10 of its ownK041108 Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation · 2004
  3. Descendant · 2 generations on · 9 of its ownK080067 Iscience Interventional Ophthalmic MicrocatheterIscience Interventional · 2008 · Recalled
  4. Descendant · 3 generations on · 6 of its ownK173332 OMNI Surgical SystemSight Sciences, Inc. · 2017
  5. Descendant · 4 generations on · 2 of its ownK202678 OMNI Surgical SystemSight Sciences, Inc. · 2021
  6. Descendant · 5 generations on · 1 of its ownK232214 OMNI Surgical SystemSight Sciences, Inc. · 2023

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2004: 12008: 12017: 12020: 12021: 22023: 22025: 12026: 2
2004high 2 (2021) · low 0 (2005)2026

Most influential descendants

Showing 5 of 11 · See all
  • K041108Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation · 2004 · cites it directly10descendants
  • K080067Iscience Interventional Ophthalmic MicrocatheterIscience Interventional · 2008 · 2 generations on9descendants
  • K173332OMNI Surgical SystemSight Sciences, Inc. · 2017 · 3 generations on6descendants
  • K202678OMNI Surgical SystemSight Sciences, Inc. · 2021 · 4 generations on2descendants
  • K232214OMNI Surgical SystemSight Sciences, Inc. · 2023 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010305Weiss Retinal CannulaMicron Surgical, Inc.2001—
+1K041108Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation2004—
+2K080067Iscience Interventional Ophthalmic MicrocatheterIscience Interventional20082
+3K173332OMNI Surgical SystemSight Sciences, Inc.2017—
+4K202678OMNI Surgical SystemSight Sciences, Inc.2021—
+5K232214OMNI Surgical SystemSight Sciences, Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200810
201710
202010
202120
202320
202510
202620
FIG. 1 — Lineage of K010305, 2001–2026Source: 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 HMX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K041108Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation200410

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, K041108 (Iscience Surgical Corporation, 2004) has gone furthest, with 10 descendants of its own.

How does its category compare?

All HMX devices

HMX Cannula, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HMX

FDA has decided no HMX device since 2007.

Median 510(k) review, days · HMX

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

Recalls per year · HMX

1in 2025

2007: 12008: 12010: 62012: 1, 1 Class I2013: 12018: 22019: 62025: 1
2007high 6 (2010) · low 0 (2009)2026

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

Adverse event reports per year · HMX

101in 2025

2007: 42008: 92009: 122010: 142011: 112012: 142013: 82014: 182015: 182016: 362017: 272018: 382019: 272020: 272021: 412022: 462023: 932024: 1002025: 101
2007high 101 (2025) · low 4 (2007)2025

MAUDE reports naming product code HMX, 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—14
20080—19
20090—012
20100—614
20110—011
20120—1 (1)14
20130—18
20140—018
20150—018
20160—036
20170—027
20180—238
20190—627
20200—027
20210—041
20220—046
20230—093
20240—0100
20250—1101
20260—0—

Recent decisions in HMX

The HMX category page

  • K000457Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic Therapy Pak, Model 12000…Retinalabs.Com · 2000
  • K970873Endosoft Soft Tip Needle (20 GA. and 19 GA.)American Medical Devices, Inc. · 1997
  • K943932Steriseal Ophthalmic CannulaPharma-Plast, Ltd. · 1995
  • K942403Infusion CannulaMicrosurgical Technology, Inc. · 1994
  • K934844Inter Tip TMicrosurgical Technology, Inc. · 1994

https://510kreport.com/device/K010305 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010305: Weiss Retinal Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010305

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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