510(k) · Cleared
ClearedGrieshaber Micro Lite Light Pipe 19 & 20 Gauge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grieshaber & Co. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Cleared on Nov 16, 1988 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Nov 16, 1988
- Review
- 51 days
- Class
- Class II
- Product code
- HQE
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK884043 Grieshaber Micro Lite Light Pipe 19 & 20 GaugeGrieshaber & Co. · 1988
- Descendant · cites it directly · 11 of its ownK973293 Syntec True Light End Irrigating EndoilluminatorVaughan Weeks · 1997
- Descendant · 2 generations on · 10 of its ownK041108 Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation · 2004
- Descendant · 2 generations on · 9 of its ownK080067 Iscience Interventional Ophthalmic MicrocatheterIscience Interventional · 2008 · Recalled
- Descendant · 3 generations on · 6 of its ownK173332 OMNI Surgical SystemSight Sciences, Inc. · 2017
- Descendant · 4 generations on · 2 of its ownK202678 OMNI Surgical SystemSight Sciences, Inc. · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K973293Syntec True Light End Irrigating EndoilluminatorVaughan Weeks · 1997 · cites it directly11descendants
- K041108Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation · 2004 · 2 generations on10descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K884043 | Grieshaber Micro Lite Light Pipe 19 & 20 Gauge | Grieshaber & Co. | 1988 | — |
| +1 | K973293 | Syntec True Light End Irrigating Endoilluminator | Vaughan Weeks | 1997 | — |
| +2 | K041108 | Iscience Surgical Ophthalmic Microcannula | Iscience Surgical Corporation | 2004 | — |
| +2 | K080067 | Iscience Interventional Ophthalmic Microcatheter | Iscience Interventional | 2008 | 2 |
| +3 | K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017 | — |
| +4 | K202678 | OMNI Surgical System | Sight Sciences, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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 HQE? 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 HQE device
- #1 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall
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? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973293 | Syntec True Light End Irrigating Endoilluminator | 1997 | 11 |
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, K973293 (Vaughan Weeks, 1997) has gone furthest, with 11 descendants of its own.
How does its category compare?
All HQE devicesHQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQE
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HQE
Too few HQE 510(k)s in any year since 2007 to give a median.
Recalls per year · HQE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQE
339in 2025
MAUDE reports naming product code HQE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 300 |
| 2008 | 0 | — | 0 | 65 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 11 | 27 |
| 2011 | 1 | — | 0 | 21 |
| 2012 | 2 | — | 0 | 34 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 4 | 10 |
| 2017 | 1 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 309 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 108 |
| 2024 | 0 | — | 0 | 105 |
| 2025 | 0 | — | 1 | 339 |
| 2026 | 0 | — | 3 | — |
https://510kreport.com/device/K884043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K884043: Grieshaber Micro Lite Light Pipe 19 & 20 Gauge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884043
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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