510(k) · Cleared
ClearedDORA Disposable A.V. Fistula Needle Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bain Medical Equipment (Guangzhou) Co., Ltd. · FIE Needle, Fistula
Cleared on Jul 20, 2017 as substantially equivalent to K071145 (Nipro Medical Corporation, 2007) after a 262-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jul 20, 2017
- Review
- 262 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932074 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK163025 DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK213015 DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. · 2022 · cites it directly0descendants
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) | K163025 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017 | — |
| +1 | K213015 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K071145 | Nipro Safetouch Tulip Safety Fistula NeedleSummary page 6…Nipro Medical Corp. Hemodialysis 5. Identification of Predicate Device 510(k) Number: K071145 Product Name: NIPRO SafeTouch TULIPTM Safety Fistula Needle Manufacturer: NIPRO Medical Corporation 6. Non-Clinical… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213015 | DORA Disposable A.V. Fistula Needle Sets | 2022 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 13.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K213015 (Bain Medical Equipment (Guangzhou) Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 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. 2017, 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 DORA 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.
The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163025: DORA Disposable A.V. Fistula Needle Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163025
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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