510(k) · Cleared
ClearedExel Vacuum Blood Collecting System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exel Intl. · FMI Needle, Hypodermic, Single Lumen
Cleared on May 6, 1986 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 6, 1986
- Review
- 41 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK861152 Exel Vacuum Blood Collecting SystemExel Intl. · 1986
- Descendant · cites it directly · 2 of its ownK992699 Nipro Blood Collection NeedleNipro Medical Corp. · 2000
- Descendant · cites it directly · 2 of its ownK992729 Nipro Luer AdaptorNipro Medical Corp. · 2000
- Descendant · 2 generations on · 1 of its ownK090426 Vaku-8 Blood Collection NeedlesMyco Medical Supplies, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK021941 Samplok Luer KitItl Corporation Pty, Ltd. · 2002
- Descendant · 3 generations on · 0 of its ownK153388 IMPROSAFE Blood Collection Set with Pre-attached Holder…Guangzhou Improve Medical Instruments Co., Ltd. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K992699Nipro Blood Collection NeedleNipro Medical Corp. · 2000 · cites it directly2descendants
- K992729Nipro Luer AdaptorNipro Medical Corp. · 2000 · cites it directly2descendants
- K090426Vaku-8 Blood Collection NeedlesMyco Medical Supplies, Inc. · 2009 · 2 generations on1descendant
- K021941Samplok Luer KitItl Corporation Pty, Ltd. · 2002 · 2 generations on1descendant
- K153388IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection…Guangzhou Improve Medical Instruments Co., Ltd. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861152 | Exel Vacuum Blood Collecting System | Exel Intl. | 1986 | — |
| +1 | K992699 | Nipro Blood Collection Needle | Nipro Medical Corp. | 2000 | — |
| +1 | K992729 | Nipro Luer Adaptor | Nipro Medical Corp. | 2000 | — |
| +2 | K090426 | Vaku-8 Blood Collection Needles | Myco Medical Supplies, Inc. | 2009 | — |
| +2 | K021941 | Samplok Luer Kit | Itl Corporation Pty, Ltd. | 2002 | — |
| +3 | K153388 | IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood… | Guangzhou Improve Medical Instruments Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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, K992699 (Nipro Medical Corp., 2000) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
https://510kreport.com/device/K861152 · printed Nov 5, 2026
Cite this page
510(k) Report. “K861152: Exel Vacuum Blood Collecting System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K861152
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026