510(k) · Cleared
Recalled · 2007Myelotec Myeloscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myelotec, Inc. · HRX Arthroscope
Cleared on Sep 4, 1996 as substantially equivalent to K930191 (Sofamor Danek Mfg., Inc., 1995) after a 232-day review. Its family tree reaches back 1 generation to 1995. It has been recalled once.
- Decided
- Sep 4, 1996
- Review
- 232 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930191 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK930191 Danek (TM) Spinal Epidural Endoscopic SYSofamor Danek Mfg., Inc. · 1995
- This deviceK960194 Myelotec MyeloscopeMyelotec, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930191 | Danek (TM) Spinal Epidural Endoscopic SY | Sofamor Danek Mfg., Inc. | 1995 | — |
| 0 (this device) | K960194 | Myelotec Myeloscope | Myelotec, Inc. | 1996 | — |
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930191 | Danek (TM) Spinal Epidural Endoscopic SYSummary page 4…yeloscope is similar in design and/or intended use to several legally marketed flexible fiberscope endoscopes. These include the Danek Spinal Epidural Endoscope Systems (K930191) and the Uiltra-Vu Endoscope Systems (K913129). These are flexible fiberoptic systems used for "micro-endoscopic” applications in… | 1995 |
| Kept off the family tree | K913129 | FDA’s K913129 is Angiolaz Angioscope Catheter Our OCR of the scanned summary read K913129, FDA’s number for Angiolaz Angioscope Catheter (Angiolaz, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Ultra-Vu Endoscope Systems”. Kept off the family tree. Summary page 4…use to several legally marketed flexible fiberscope endoscopes. These include the Danek Spinal Epidural Endoscope Systems (K930191) and the Uiltra-Vu Endoscope Systems (K913129). These are flexible fiberoptic systems used for "micro-endoscopic” applications in small body cavities and spaces. Description… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2007 | Not classified | Z-0586-2008 | Error in labeling | Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Myeloscope is intended to be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.
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/K960194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960194: Myelotec Myeloscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960194
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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