510(k) · Cleared
ClearedNipro Biohole Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corp. · FIE Needle, Fistula
Cleared on Feb 5, 2007 as substantially equivalent to K955182 (Nissho Corp., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1983.
- Decided
- Feb 5, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K823068 (1983). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K823068 | Medisystems Fistula Needles | Medisystems Corp. | 1983 | — |
| −1 | K990803 | Medisystems Buttonhole Needle Sets | Medisystems Corp. | 2000 | 1 |
| 0 (this device) | K063368 | Nipro Biohole Needle | Nipro Medical Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 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 FIE? 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 FIE device
- #1 K253469 Ritus™ Safety Fistula Cannula with Anti-Reflux…score 13.0 · 5 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 |
|---|---|---|---|
| * | K955182 | Nipro Arterial Venous Fistula NeedleSummary page 1…ries (21 CFR 876.5540) Product Code: 78 FIE 807.92(a)(3) Legally marketed substantial equivalent device: NIPRO AVE Needle (K955182) Medisystems ButtonHole Needle Set (K990803) 807.92(a)(4) Description of device: T… | 1996 |
| * | K990803 | Medisystems Buttonhole Needle SetsSummary page 1…807.92(a)(3) Legally marketed substantial equivalent device: NIPRO AVE Needle (K955182) Medisystems ButtonHole Needle Set (K990803) 807.92(a)(4) Description of device: The NIPRO BioHole Tm Needle is a sterile, single-use devic… | 2000 |
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?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 16.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K955182.
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FIE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FIE
91in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FIE
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FIE
33in 2025
MAUDE reports naming product code FIE, 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 | 3 | 90 | 0 | 13 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 27 |
| 2010 | 3 | 29 | 0 | 17 |
| 2011 | 3 | 91 | 0 | 2 |
| 2012 | 1 | — | 3 | 7 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 2 | — | 0 | 23 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 1 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 21 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 58 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The NIPRO BioHole™ Needle is intended for use as a blood access device for dialysis procedures using a constant-site cannulation technique of needle insertion with an established, mature constant-site also known as a buttonhole access site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063368 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063368: Nipro Biohole Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063368
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