510(k) · Cleared
ClearedNipro Luer Adaptor
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 Jan 13, 2000 as substantially equivalent to K861152 (Exel Intl., 1986) after a 153-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.
- Decided
- Jan 13, 2000
- Review
- 153 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 deviceK992729 Nipro Luer AdaptorNipro Medical Corp. · 2000
- Descendant · cites it directly · 1 of its ownK021941 Samplok Luer KitItl Corporation Pty, Ltd. · 2002
- Descendant · 2 generations on · 0 of its ownK120490 Quick Sampler HolderNipro Medical Corporation · 2012
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) | K992729 | Nipro Luer Adaptor | Nipro Medical Corp. | 2000 | — |
| +1 | K021941 | Samplok Luer Kit | Itl Corporation Pty, Ltd. | 2002 | — |
| +2 | K120490 | Quick Sampler Holder | Nipro Medical Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2012 | 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…ment Registration Number: 9611446 Class: 11 Panel: 80 Procodes: FOZ §807.92 (a)(3) Legally Marketed Substantially Equivalent Device: Exel International Luer Adaptor (K861152A) §807.92 (a)(4) Description of Device: The Nipro Luer Adaptor that we intend to market is a multi-type with a cannula that has… | 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 |
|---|---|---|---|
| K021941 | Samplok Luer Kit | 2002 | 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 Luer Adaptor is intended to be used as an attachment for a needle with a luer taper hub for blood collection. The luer adaptor is used as part of the vacuum blood collection equipment for blood collection required 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/K992729 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992729: Nipro Luer Adaptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992729
Report an extraction error
Are you the manufacturer?
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