510(k) · Cleared
ClearedAplan a.V. Fistula Needle Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aplan Well Enterprise Co., Ltd. · FIE Needle, Fistula
Cleared on Apr 24, 2012 as substantially equivalent to K990470 (Jms Co., Ltd., 1999) after a 217-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Apr 24, 2012
- Review
- 217 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990470 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK990470 JMS a. V. Fistula Needle SetJms Co., Ltd. · 1999
- This deviceK112734 Aplan a.V. Fistula Needle SetAplan Well Enterprise Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990470 | JMS a. V. Fistula Needle Set | Jms Co., Ltd. | 1999 | — |
| 0 (this device) | K112734 | Aplan a.V. Fistula Needle Set | Aplan Well Enterprise Co., Ltd. | 2012 | — |
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 |
|---|---|---|---|
| * | K990470 | JMS a. V. Fistula Needle SetSummary page 1…ion * Predicate Device: Claim of Substantial Equivalence (SE) is made to JMS North America Corp. A.V. Fistula Needle Set for Single Use (K(990470) * Device Description: AXV Fistula Needle Set is a single-use fistula needle which is inserted for t… | 1999 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K990470.
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 A. V. Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device is intended for single use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112734 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112734: Aplan a.V. Fistula Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112734
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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