510(k) · Cleared
ClearedNipro Coreless Needle/Coreless Needle Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corp. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Dec 22, 1997 as substantially equivalent to K895769 (Exel Intl., 1990) and 1 other predicate after a 236-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Dec 22, 1997
- Review
- 236 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K895769 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK895769 Exel Huber NeedleExel Intl. · 1990 · Recalled
- This deviceK971582 Nipro Coreless Needle/Coreless Needle SetNipro Medical Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895769 | Exel Huber Needle | Exel Intl. | 1990 | 1 |
| 0 (this device) | K971582 | Nipro Coreless Needle/Coreless Needle Set | Nipro Medical Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 LJT? 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 LJT device
- #1 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K895769 | Exel Huber NeedleSummary page 1…lar administration set (21 CFR §880.5440) §807.92 (2)(3) Legally Marketed Substantially Equivalent Device: Huber Needle and Huber Needle Set, Exel International, Inc. (K895769 and K895770) §807.92 (a)(4) Description of Device: Nipro Coreless Needles and Nipro Coreless Needle Sets are described in Hypod… | 1990 |
| * | K895770 | Exel Huber Infusion SetSummary page 1…ration set (21 CFR §880.5440) §807.92 (2)(3) Legally Marketed Substantially Equivalent Device: Huber Needle and Huber Needle Set, Exel International, Inc. (K895769 and K895770) §807.92 (a)(4) Description of Device: Nipro Coreless Needles and Nipro Coreless Needle Sets are described in Hypodermic single… | 1990 |
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?
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K895769.
How does its category compare?
All LJT devicesLJT Port & Catheter, Implanted, Subcutaneous, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJT
182in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJT
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LJT
4,308in 2025
MAUDE reports naming product code LJT, 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 | 11 | 85 | 1 | 208 |
| 2008 | 7 | 119 | 2 | 161 |
| 2009 | 2 | — | 2 | 172 |
| 2010 | 2 | — | 19 | 207 |
| 2011 | 5 | 144 | 1 | 202 |
| 2012 | 2 | — | 2 | 153 |
| 2013 | 7 | 150 | 0 | 141 |
| 2014 | 2 | — | 0 | 143 |
| 2015 | 4 | 164 | 1 | 149 |
| 2016 | 3 | 182 | 0 | 135 |
| 2017 | 0 | — | 1 | 262 |
| 2018 | 0 | — | 1 | 878 |
| 2019 | 1 | — | 7 | 765 |
| 2020 | 1 | — | 0 | 959 |
| 2021 | 0 | — | 0 | 1,285 |
| 2022 | 0 | — | 1 | 1,334 |
| 2023 | 1 | — | 0 | 1,221 |
| 2024 | 1 | — | 0 | 1,896 |
| 2025 | 2 | — | 0 | 4,308 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The Nipro Coreless Needle and the Nipro Coreless Needle Set, for which coring is prevented, are intended to be used to inject a drug solution into a reservoir implanted in the body.
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/K971582 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971582: Nipro Coreless Needle/Coreless Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971582
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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