510(k) · Cleared
ClearedLeonard Arm - Support Arm - Endoscopic Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leonard Medical, Inc. · FQO Table, Operating-Room, Ac-Powered
Cleared on Jun 21, 1995 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Jun 21, 1995
- Review
- 61 days
- Class
- Class I
- Product code
- FQO
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK951854 Leonard Arm - Support Arm - Endoscopic AccessoryLeonard Medical, Inc. · 1995
- Descendant · cites it directly · 10 of its ownK992006 Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC · 1999
- Descendant · 2 generations on · 9 of its ownK050051 Armand Endoscope HolderKLS-Martin L.P. · 2005
- Descendant · 2 generations on · 4 of its ownK070509 Fisso Holding SystemBaitella AG · 2007
- Descendant · cites it directly · 4 of its ownK973543 Kronner Low Profile Scope HolderKronner Prototypes, Inc. · 1998
- Descendant · 3 generations on · 2 of its ownK190576 WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K992006Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC · 1999 · cites it directly10descendants
- K050051Armand Endoscope HolderKLS-Martin L.P. · 2005 · 2 generations on9descendants
- K070509Fisso Holding SystemBaitella AG · 2007 · 2 generations on4descendants
- K973543Kronner Low Profile Scope HolderKronner Prototypes, Inc. · 1998 · cites it directly4descendants
- K190576WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951854 | Leonard Arm - Support Arm - Endoscopic Accessory | Leonard Medical, Inc. | 1995 | — |
| +1 | K992006 | Neuroview Instrument Holder, Model 300-33 | Integra Neurocare, LLC | 1999 | — |
| +2 | K050051 | Armand Endoscope Holder | KLS-Martin L.P. | 2005 | — |
| +2 | K070509 | Fisso Holding System | Baitella AG | 2007 | — |
| +1 | K973543 | Kronner Low Profile Scope Holder | Kronner Prototypes, Inc. | 1998 | — |
| +3 | K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Biomet Microfixation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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 FQO? 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 FQO device
- #1 K240598 Maestro System (REF100)score 10.7 · 2 generations · no Class I recall
- #2 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? (16)
See all 163 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, K992006 (Integra Neurocare, LLC, 1999) has gone furthest, with 10 descendants of its own.
How does its category compare?
All FQO devicesFQO Table, Operating-Room, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FQO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FQO
Too few FQO 510(k)s in any year since 2007 to give a median.
Recalls per year · FQO
8in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FQO
113in 2025
MAUDE reports naming product code FQO, 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 | — | 0 | 61 |
| 2008 | 0 | — | 10 | 47 |
| 2009 | 1 | — | 3 | 58 |
| 2010 | 0 | — | 3 | 127 |
| 2011 | 0 | — | 7 | 101 |
| 2012 | 0 | — | 0 | 120 |
| 2013 | 0 | — | 1 | 116 |
| 2014 | 0 | — | 1 | 145 |
| 2015 | 0 | — | 2 | 108 |
| 2016 | 0 | — | 2 | 93 |
| 2017 | 0 | — | 0 | 98 |
| 2018 | 0 | — | 5 | 104 |
| 2019 | 0 | — | 0 | 118 |
| 2020 | 0 | — | 2 | 97 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 1 | — | 1 | 125 |
| 2023 | 0 | — | 2 | 187 |
| 2024 | 1 | — | 8 | 139 |
| 2025 | 0 | — | 0 | 113 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K951854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951854: Leonard Arm - Support Arm - Endoscopic Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951854
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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