510(k) · Cleared
ClearedNipro Blood Collection Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corp. · FMI Needle, Hypodermic, Single Lumen
Cleared on Feb 14, 2000 as substantially equivalent to K861152 (Exel Intl., 1986) after a 186-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.
- Decided
- Feb 14, 2000
- Review
- 186 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K861152 (1986). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK861152 Exel Vacuum Blood Collecting SystemExel Intl. · 1986
- This deviceK992699 Nipro Blood Collection NeedleNipro Medical Corp. · 2000
- Descendant · cites it directly · 1 of its ownK090426 Vaku-8 Blood Collection NeedlesMyco Medical Supplies, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK153388 IMPROSAFE Blood Collection Set with Pre-attached Holder…Guangzhou Improve Medical Instruments Co., Ltd. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861152 | Exel Vacuum Blood Collecting System | Exel Intl. | 1986 | — |
| 0 (this device) | K992699 | Nipro Blood Collection Needle | Nipro Medical Corp. | 2000 | — |
| +1 | K090426 | Vaku-8 Blood Collection Needles | Myco Medical Supplies, Inc. | 2009 | — |
| +2 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 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 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? (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 |
|---|---|---|---|
| * | K861152 | Exel Vacuum Blood Collecting SystemSummary page 1…ration Number: 9611446 Class: 11 Panel: 80 Procodes: FMI §807.92 (a)(3) Legally Marketed Substantially Equivalent Device: Exel International Blood collection needle (K861152A) §807.92 (a)(4) Description of Device: The Nipro Blood collection needles that we intend to market include gauges 18, 20, 21,… | 1986 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090426 | Vaku-8 Blood Collection Needles | 2009 | 1 |
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?
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) | — |
What is it indicated for?
The Nipro Blood Collection Needle are intended to be used to collect blood for various blood tests.
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/K992699 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992699: Nipro Blood Collection Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992699
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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