510(k) · Cleared
ClearedHARBOR Occlusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvascular, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Jun 12, 2026 as substantially equivalent to K250133 (Nuvascular, Inc., 2025) after a 106-day review. Its family tree reaches back 10 generations to 1989.
- Decided
- Jun 12, 2026
- Review
- 106 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K891688 (1989). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK891688 Coil and Coil Delivery SystemTarget Therapeutics · 1989
- 6 generations between
- 3 generations backK071699 Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020…Aga Medical Corp. · 2007
- 2 generations backK113658 Amplatzer Vascular Plug 4Aga Medical Corp. · 2012
- 1 generation backK250133 HARBOR Occlusion DeviceNuvascular, Inc. · 2025
- This deviceK260635 HARBOR Occlusion DeviceNuvascular, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK891688 Coil and Coil Delivery SystemTarget Therapeutics · 1989
- 9 generations backK964367 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997
- 8 generations backK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
- 7 generations backK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
- 6 generations backK993455 Flipper Detachable Embolization CoilCook, Inc. · 2000
- 5 generations backK031810 Amplatzer Vascular PlugAga Medical Corp. · 2003 · Recalled
- 4 generations backK071125 Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008…Aga Medical Corp. · 2007
- 3 generations backK071699 Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020…Aga Medical Corp. · 2007
- 2 generations backK113658 Amplatzer Vascular Plug 4Aga Medical Corp. · 2012
- 1 generation backK250133 HARBOR Occlusion DeviceNuvascular, Inc. · 2025
- This deviceK260635 HARBOR Occlusion DeviceNuvascular, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K891688 | Coil and Coil Delivery System | Target Therapeutics | 1989 | — |
| −9 | K964367 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1997 | — |
| −8 | K972881 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1998 | — |
| −7 | K983483 | Vascular Occlusion System | Cordis Neurovascular, Inc. | 1999 | — |
| −6 | K993455 | Flipper Detachable Embolization Coil | Cook, Inc. | 2000 | — |
| −5 | K031810 | Amplatzer Vascular Plug | Aga Medical Corp. | 2003 | 1 |
| −4 | K071125 | Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010… | Aga Medical Corp. | 2007 | — |
| −3 | K071699 | Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022 | Aga Medical Corp. | 2007 | — |
| −2 | K113658 | Amplatzer Vascular Plug 4 | Aga Medical Corp. | 2012 | — |
| −1 | K250133 | HARBOR Occlusion Device | Nuvascular, Inc. | 2025 | — |
| 0 (this device) | K260635 | HARBOR Occlusion Device | Nuvascular, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 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 KRD? 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 KRD device
- #1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K250133 | HARBOR Occlusion DeviceSummary page 5…ice, Vascular, for promoting embolization Regulatory Class: Class II, 21 CFR 870.3300 Product Code: KRD PREDICATE DEVICE Nuvascular Inc.: HARBOR Occlusion Device (KRD) (K250133) DEVICE DESCRIPTION The HARBOR Occlusion Device is a self-expanding braided nitinol arterial embolization implant (Figure 1) sup… | 2025 |
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 37 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 19 ancestors have a recall of any class.
How does its category compare?
All KRD devicesKRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · KRD
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRD
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRD
1,572in 2025
MAUDE reports naming product code KRD, 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 | 2 | — | 0 | 21 |
| 2008 | 5 | 84 | 0 | 14 |
| 2009 | 4 | 27 | 0 | 40 |
| 2010 | 3 | 150 | 1 | 61 |
| 2011 | 5 | 36 | 0 | 102 |
| 2012 | 8 | 30 | 0 | 137 |
| 2013 | 11 | 33 | 1 | 244 |
| 2014 | 7 | 134 | 0 | 159 |
| 2015 | 11 | 130 | 0 | 337 |
| 2016 | 4 | 164 | 0 | 437 |
| 2017 | 4 | 89 | 0 | 736 |
| 2018 | 4 | 62 | 0 | 1,066 |
| 2019 | 6 | 178 | 0 | 1,185 |
| 2020 | 4 | 137 | 0 | 1,167 |
| 2021 | 3 | 134 | 0 | 1,444 |
| 2022 | 8 | 175 | 0 | 1,498 |
| 2023 | 2 | — | 1 | 1,371 |
| 2024 | 6 | 70 | 1 | 1,535 |
| 2025 | 9 | 60 | 0 | 1,572 |
| 2026 | 7 | 70 | 1 | — |
What is it indicated for?
The HARBOR Occlusion Device is indicated for arterial embolization in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260635: HARBOR Occlusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260635
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026