510(k) · Cleared
ClearedEmerald Medical, Inc. Nucleus Pulposis Evacuator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emerald Medical, Inc. · HRX Arthroscope
Cleared on Jan 28, 1997 as substantially equivalent to K941709 (Acufex Microsurgical, Inc., 1995) after a 50-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jan 28, 1997
- Review
- 50 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941709 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK941709 Acufex Arthroscopic Discectomy SystemsAcufex Microsurgical, Inc. · 1995
- This deviceK964919 Emerald Medical, Inc. Nucleus Pulposis Evacuator SystemEmerald Medical, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941709 | Acufex Arthroscopic Discectomy Systems | Acufex Microsurgical, Inc. | 1995 | — |
| 0 (this device) | K964919 | Emerald Medical, Inc. Nucleus Pulposis Evacuator System | Emerald Medical, Inc. | 1997 | — |
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? (6)
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 |
|---|---|---|---|
| * | K941709 | Acufex Arthroscopic Discectomy SystemsSummary page 1…antially equivalent technology and materials as the predicate disc removal tools utilized in the Acufex Microsurgical Jnterceptre Arthroscopic Discectomy System, 510 (k) K941709, and the Smith & Nephew Arthroscapic MicraDiscectomy System, AMD™. The proposed introduction kit contains the same components as… | 1995 |
| * | — | Smith & Nephew Arthroscopic MicroDiscectomy System (AMD) Named without a submission number | |
| * | — | Instrument introduction system developed by Acufex Microsurgical Named without a submission number | |
| * | — | Instrument introduction system developed by Surgical Dynamics Named without a submission number | |
| * | — | Instrument introduction system developed by Sofamor Danek Named without a submission number | |
| * | — | Instrument introduction system developed by Smith & Nephew Spine Named without a submission number |
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?
- 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 | — |
https://510kreport.com/device/K964919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964919: Emerald Medical, Inc. Nucleus Pulposis Evacuator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964919
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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