510(k) · Cleared
ClearedSpinal Foraminoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blazejewski Medi-Tech GmbH · HRX Arthroscope
Cleared on Sep 9, 2009 as substantially equivalent to K973405 (Richard Wolf Medical Instruments Corp., 1998) and 2 other predicates after a 348-day review. Its family tree reaches back 1 generation to 1995. 20 later devices descend from it.
- Decided
- Sep 9, 2009
- Review
- 348 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K953484 (1995). 3 ancestors in all. 20 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK953484 Pollux OA/Pollux 30A/Pollux 70APollux Endoscopy, Inc. · 1995
- This deviceK082841 Spinal ForaminoscopeBlazejewski Medi-Tech GmbH · 2009
- Descendant · cites it directly · 14 of its ownK130778 Discoscopes, Cervical EndoscopesRz Medizintechnik GmbH · 2014
- Descendant · 2 generations on · 12 of its ownK180766 Endiscope, Endiscope CervicalElliquence, LLC · 2018
- Descendant · 3 generations on · 11 of its ownK201134 Arthrex NanoScope SystemArthrex, Inc. · 2020
- Descendant · 4 generations on · 4 of its ownK243008 Arthrex NanoScope SystemArthrex, Inc. · 2025
- Descendant · 4 generations on · 4 of its ownK223759 Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K130778Discoscopes, Cervical EndoscopesRz Medizintechnik GmbH · 2014 · cites it directly14descendants
- K180766Endiscope, Endiscope CervicalElliquence, LLC · 2018 · 2 generations on12descendants
- K201134Arthrex NanoScope SystemArthrex, Inc. · 2020 · 3 generations on11descendants
- K243008Arthrex NanoScope SystemArthrex, Inc. · 2025 · 4 generations on4descendants
- K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953484 | Pollux OA/Pollux 30A/Pollux 70A | Pollux Endoscopy, Inc. | 1995 | — |
| 0 (this device) | K082841 | Spinal Foraminoscope | Blazejewski Medi-Tech GmbH | 2009 | — |
| +1 | K130778 | Discoscopes, Cervical Endoscopes | Rz Medizintechnik GmbH | 2014 | — |
| +2 | K180766 | Endiscope, Endiscope Cervical | Elliquence, LLC | 2018 | — |
| +3 | K201134 | Arthrex NanoScope System | Arthrex, Inc. | 2020 | — |
| +4 | K243008 | Arthrex NanoScope System | Arthrex, Inc. | 2025 | — |
| +4 | K223759 | Arthrex SynergyID Endoscopic Imaging System | Arthex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 0 |
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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K973405 | Yeung Endoscopic Spine SystemSummary page 1…Classification Name: Arthroscope Predicate . Yeung Endoscopic Spine System, Richard Wolf Medical Devices: Instruments Corp., K973405 . Spine Scope, Model 2180, Clarus Medical, LLC., K011454 Pollux Arthros… | 1998 |
| * | K011454 | Spine Scope, Model 2180Summary page 1…Spine System, Richard Wolf Medical Devices: Instruments Corp., K973405 . Spine Scope, Model 2180, Clarus Medical, LLC., K011454 Pollux Arthroscopes, Pollux Endoscopy, Inc., K953484 Device The Spinal Foramin… | 2001 |
| * | K953484 | Pollux OA/Pollux 30A/Pollux 70ASummary page 1…, K973405 . Spine Scope, Model 2180, Clarus Medical, LLC., K011454 Pollux Arthroscopes, Pollux Endoscopy, Inc., K953484 Device The Spinal Foraminoscope for lumbar access is an optical and Description: fiberoptic-b… | 1995 |
What descends from it? (20)
See all 203 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?
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The Spinal Foraminoscope for lumbar access is indicated for endoscopic visualization in the lumbar region. The Spinal Foraminoscope for cervical access is indicated for visual inspection of the cervical spinal nerve root and tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082841 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082841: Spinal Foraminoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082841
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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