510(k) · Cleared
ClearedHemoband, Models HB-NS and HB-NSXL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovations For Access, Inc. · KOC Accessories, Blood Circuit, Hemodialysis
Cleared on Mar 12, 2009 after a 266-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Mar 12, 2009
- Review
- 266 days
- Class
- Class II
- Product code
- KOC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK081740 Hemoband, Models HB-NS and HB-NSXLInnovations For Access, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK142122 Radar Vascular Compression DeviceAdvanced Vascular Dynamics · 2014
- Descendant · cites it directly · 3 of its ownK142359 Vasc Band hemostatLepu Medical Technology (Beijing) Co., Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK162988 PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK151363 Zephyr Vascular Compression DeviceAdvanced Vascular Dynamics · 2015
- Descendant · 3 generations on · 0 of its ownK262086 PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K142122Radar Vascular Compression DeviceAdvanced Vascular Dynamics · 2014 · cites it directly3descendants
- K142359Vasc Band hemostatLepu Medical Technology (Beijing) Co., Ltd. · 2014 · cites it directly3descendants
- K162988PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc. · 2017 · 2 generations on1descendant
- K151363Zephyr Vascular Compression DeviceAdvanced Vascular Dynamics · 2015 · 2 generations on1descendant
- K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081740 | Hemoband, Models HB-NS and HB-NSXL | Innovations For Access, Inc. | 2009 | — |
| +1 | K142122 | Radar Vascular Compression Device | Advanced Vascular Dynamics | 2014 | — |
| +1 | K142359 | Vasc Band hemostat | Lepu Medical Technology (Beijing) Co., Ltd. | 2014 | — |
| +2 | K162988 | PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. | 2017 | 1 |
| +2 | K151363 | Zephyr Vascular Compression Device | Advanced Vascular Dynamics | 2015 | — |
| +3 | K262086 | PreludeSYNC™ Radial Compression Device | Merit Medical Systems, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KOC? 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 KOC device
- #1 K230514 Blood Tubing Lines for Hemodialysis AL Series…score 11.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
2 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?
- Of its descendants, K142122 (Advanced Vascular Dynamics, 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KOC devicesKOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KOC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KOC
Too few KOC 510(k)s in any year since 2007 to give a median.
Recalls per year · KOC
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOC
50in 2025
MAUDE reports naming product code KOC, 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 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 2 | 12 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 22 |
| 2014 | 1 | — | 1 | 165 |
| 2015 | 2 | — | 0 | 555 |
| 2016 | 1 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 23 |
| 2018 | 0 | — | 3 | 37 |
| 2019 | 0 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 18 |
| 2025 | 2 | — | 0 | 50 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The HemoBand is used to provide pressure hemostasis of arterial, venous and dialysis access needle puncture sites.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K081740 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081740: Hemoband, Models HB-NS and HB-NSXL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081740
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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