510(k) · Cleared
ClearedDiscoscopes, Cervical Endoscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rz Medizintechnik GmbH · HRX Arthroscope
Cleared on Apr 14, 2014 as substantially equivalent to K051827 (Joimax GmbH, 2005) and 1 other predicate after a 389-day review. Its family tree reaches back 2 generations to 1995. 14 later devices descend from it.
- Decided
- Apr 14, 2014
- Review
- 389 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K953484 (1995). 5 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK953484 Pollux OA/Pollux 30A/Pollux 70APollux Endoscopy, Inc. · 1995
- 1 generation backK082841 Spinal ForaminoscopeBlazejewski Medi-Tech GmbH · 2009
- This deviceK130778 Discoscopes, Cervical EndoscopesRz Medizintechnik GmbH · 2014
- Descendant · cites it directly · 12 of its ownK180766 Endiscope, Endiscope CervicalElliquence, LLC · 2018
- Descendant · 2 generations on · 11 of its ownK201134 Arthrex NanoScope SystemArthrex, Inc. · 2020
- Descendant · 3 generations on · 4 of its ownK243008 Arthrex NanoScope SystemArthrex, Inc. · 2025
- Descendant · 3 generations on · 4 of its ownK223759 Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023
- Descendant · 4 generations on · 3 of its ownK233451 Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K180766Endiscope, Endiscope CervicalElliquence, LLC · 2018 · cites it directly12descendants
- K201134Arthrex NanoScope SystemArthrex, Inc. · 2020 · 2 generations on11descendants
- K243008Arthrex NanoScope SystemArthrex, Inc. · 2025 · 3 generations on4descendants
- K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023 · 3 generations on4descendants
- K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953484 | Pollux OA/Pollux 30A/Pollux 70A | Pollux Endoscopy, Inc. | 1995 | — |
| −1 | K082841 | Spinal Foraminoscope | Blazejewski Medi-Tech GmbH | 2009 | — |
| 0 (this device) | K130778 | Discoscopes, Cervical Endoscopes | Rz Medizintechnik GmbH | 2014 | — |
| +1 | K180766 | Endiscope, Endiscope Cervical | Elliquence, LLC | 2018 | — |
| +2 | K201134 | Arthrex NanoScope System | Arthrex, Inc. | 2020 | — |
| +3 | K243008 | Arthrex NanoScope System | Arthrex, Inc. | 2025 | — |
| +3 | K223759 | Arthrex SynergyID Endoscopic Imaging System | Arthex, Inc. | 2023 | — |
| +4 | K233451 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 7 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K051827 | Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys…Summary page 2…dy cleared by the FDA: Predicate Device 510(k) Number 510(k) Holder THESSYS Muitiscope K051827 Joimax GmbH Spinai Foranjinoscope . K082841 Blazjewski Me… | 2005 |
| * | K082841 | Spinal ForaminoscopeSummary page 2…510(k) Holder THESSYS Muitiscope K051827 Joimax GmbH Spinai Foranjinoscope . K082841 Blazjewski Medi-Tech GmbH 001_510OKSumnia ryv2… | 2009 |
What descends from it? (14)
See all 142 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 14.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K180766 (Elliquence, LLC, 2018) has gone furthest, with 12 descendants of its own.
- 7 other devices also cite its predicate K051827.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 use of RZ Medizintechnik spinal endoscopes is indicated for visualization of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130778: Discoscopes, Cervical Endoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130778
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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