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 Apr 8, 2022 as substantially equivalent to K163025 (Bain Medical Equipment (Guangzhou) Co., Ltd., 2017) after a 200-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Apr 8, 2022
- Review
- 200 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K932074 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK932074 Medisystems Apheresis Needle with GuardMedisystems Corp. · 1994
- 2 generations backK071145 Nipro Safetouch Tulip Safety Fistula NeedleNipro Medical Corporation · 2007 · Recalled
- 1 generation backK163025 DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. · 2017
- This deviceK213015 DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932074 | Medisystems Apheresis Needle with Guard | Medisystems Corp. | 1994 | — |
| −2 | K071145 | Nipro Safetouch Tulip Safety Fistula Needle | Nipro Medical Corporation | 2007 | 1 |
| −1 | K163025 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017 | — |
| 0 (this device) | 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 |
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
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 |
|---|---|---|---|
| * | K163025 | DORA Disposable A.V. Fistula Needle SetsSummary page 6…Blood Path Indirect <24 hours styrene) 5. Identification of Predicate Device 510(k) Number: K163025 Product Name: DORA Disposable A.V. Fistula Needle Sets Manufacturer: Bain Medical Equipment(Guangzhou)Co., Ltd. 6.… | 2017 |
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 28 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 is used for protecting from needlestick injury.
The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein
puncture for hemodialysis treatment.
The DORA Disposable A.V. Fistula Needle Sets (Dull Needle Series) are single-use sterile medical devices intended to
be used as vein puncture for hemodialysis treatment. Scab Remover is used for remove the scab at puncture position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213015: 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/K213015
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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