510(k) · Cleared
ClearedDimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dimesol, Inc. · FIE Needle, Fistula
Cleared on May 17, 2018 as substantially equivalent to K071145 (Nipro Medical Corporation, 2007) and 2 other predicates after a 359-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- May 17, 2018
- Review
- 359 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K932074 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK932074 Medisystems Apheresis Needle with GuardMedisystems Corp. · 1994
- 1 generation backK071145 Nipro Safetouch Tulip Safety Fistula NeedleNipro Medical Corporation · 2007 · Recalled
- This deviceK171505 Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and…Dimesol, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932074 | Medisystems Apheresis Needle with Guard | Medisystems Corp. | 1994 | — |
| −1 | K071145 | Nipro Safetouch Tulip Safety Fistula Needle | Nipro Medical Corporation | 2007 | 1 |
| 0 (this device) | K171505 | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol… | Dimesol, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 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? (3)
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 |
|---|---|---|---|
| * | K071145 | Nipro Safetouch Tulip Safety Fistula NeedleSummary page 6…510(K) SUMMARY UNDER 21 CFR 807.92 C. Legally Marketed Predicate Device Primary Predicate: NIPRO SafeTouch Tulip Safety Fistula Needle (K071145) Reference Device 1: JMS A.V. Fistula Needle Set (K990470) Reference Device 2: EXEL A.V. Fi… | 2007 |
| * | K990470 | JMS a. V. Fistula Needle SetSummary page 6…Device Primary Predicate: NIPRO SafeTouch Tulip Safety Fistula Needle (K071145) Reference Device 1: JMS A.V. Fistula Needle Set (K990470) Reference Device 2: EXEL A.V. Fistula Needle Set (K013037) D. Indications for Use (1) Safety Ser… | 1999 |
| * | K013037 | Excel a.V Fisutal Needle SetSummary page 6…istula Needle (K071145) Reference Device 1: JMS A.V. Fistula Needle Set (K990470) Reference Device 2: EXEL A.V. Fistula Needle Set (K013037) D. Indications for Use (1) Safety Series The Dimesol Disposable A.V. Fistula Needle Sets (Safety Needle Seri… | 2001 |
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 3 companies; a new generation was cleared every 13.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K071145.
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Dimesol Disposable A.V. Fistula Needle Sets are single-use sterile medical devices
intended to be used as vein puncture for hemodialysis treatment. This device is for in-hospital or hemodialysis center use only.
The Dimesol Disposable A.V. Fistula Needle Sets (Safety Needle Series) are single-use
sterile medical devices intended to be used as vein puncture for hemodialysis treatment.
Protective Shield aids in the prevention of accidental needlesticks. This device is for in-
hospital or hemodialysis center use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171505: Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171505
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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