510(k) · Cleared
ClearedDiskom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biopsybell S.R.L. · HRX Arthroscope
Cleared on Mar 26, 2018 as substantially equivalent to K141557 (Gallini Medical Devices, Srl, 2014) and 1 other predicate after a 49-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Mar 26, 2018
- Review
- 49 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K844131 (1984). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK844131 NucleotomeMedical Instrument Development Laboratories, Inc. · 1984
- 2 generations backK032473 Dekompressor Percutaneous Discectomy ProbeStryker Instruments · 2003 · Recalled
- 1 generation backK141557 Herniatome Percutaneous Disectomy Device - Cervical, Herniatome…Gallini Medical Devices, Srl · 2014 · Recalled
- This deviceK180315 DiskomBiopsybell S.R.L. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K844131 | Nucleotome | Medical Instrument Development Laboratories, Inc. | 1984 | — |
| −2 | K032473 | Dekompressor Percutaneous Discectomy Probe | Stryker Instruments | 2003 | 3 |
| −1 | K141557 | Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous… | Gallini Medical Devices, Srl | 2014 | 3 |
| 0 (this device) | K180315 | Diskom | Biopsybell S.R.L. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 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 |
|---|---|---|---|
| * | K141557 | Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous Disectomy…Summary page 4…ant Device name 510(k) Number Product code GALLINI Herniatome Percutaneous Discectomy Device K141557 HRX STRYKER Stryker Decompressor Percutaneous Discectomy Probe K032473 HRX… | 2014 |
| * | K032473 | Dekompressor Percutaneous Discectomy ProbeSummary page 4…GALLINI Herniatome Percutaneous Discectomy Device K141557 HRX STRYKER Stryker Decompressor Percutaneous Discectomy Probe K032473 HRX Page 1 / 5 === Page… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 4 companies; a new generation was cleared every 11.1 years on median.
- 2 of the 11 ancestors have a recall of any class.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 DISKOM is intended for use in aspiration of disc material during percutancous discectomics in the lumbar, thoracic and cervical regions of the spine
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/K180315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180315: Diskom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180315
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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