510(k) · Cleared
ClearedFleischman-Swartz Endo-Ocular Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hgm, Inc. · HQF Laser, Ophthalmic
Cleared on May 9, 1984 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- May 9, 1984
- Review
- 90 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK840590 Fleischman-Swartz Endo-Ocular ProbeHgm, Inc. · 1984
- Descendant · cites it directly · 5 of its ownK032357 Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2003
- Descendant · 2 generations on · 4 of its ownK052526 Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005
- Descendant · 3 generations on · 1 of its ownK062336 Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006
- Descendant · 3 generations on · 1 of its ownK061025 Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006
- Descendant · 4 generations on · 0 of its ownK123056 Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls) · 2012
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K032357Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2003 · cites it directly5descendants
- K052526Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005 · 2 generations on4descendants
- K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006 · 3 generations on1descendant
- K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006 · 3 generations on1descendant
- K123056Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls) · 2012 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K840590 | Fleischman-Swartz Endo-Ocular Probe | Hgm, Inc. | 1984 | — |
| +1 | K032357 | Novus TTX Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2003 | — |
| +2 | K052526 | Novus 3000 Laser System and Delivery Devices | Lumenis, Inc. | 2005 | — |
| +3 | K062336 | Optimedica Laser Indirect Ophthalmoscope | Optimedica Corporation | 2006 | — |
| +3 | K061025 | Accutech Endolite Probe | Accutech Medical Technologies, Inc. | 2006 | — |
| +4 | K123056 | Pascal Laser Indirect Ophthalmoscope | Topcon Medical Laser Systems, Inc. (Tmls) | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 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 HQF? 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 HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K032357 (Lumenis, Inc., 2003) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, 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 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K840590 · printed Nov 5, 2026
Cite this page
510(k) Report. “K840590: Fleischman-Swartz Endo-Ocular Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K840590
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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