510(k) · Cleared
ClearedJMS Harmony A.V. Fistula Needle Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
JMS North America Corporation · FIE Needle, Fistula
Cleared on May 13, 2015 as substantially equivalent to K093637 (Jms North America Corp., 2010) and 1 other predicate after a 27-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- May 13, 2015
- Review
- 27 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K030479 (2003). 10 ancestors in all, the oldest K823068 (1983). No later device cites it as a predicate yet.
- Root · 5 generations backK030479 JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle SetJms North America Corp. · 2003
- 4 generations backK051814 JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle SetJms North America Corp. · 2005
- 3 generations backK070234 JMS Sysloc Mini Avf and Apheresis Needle SetsJms North America Corp. · 2007
- 2 generations backK082882 A.V. Fistula Blunt Needle SetJms North America Corp. · 2009
- 1 generation backK093637 JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model…Jms North America Corp. · 2010
- This deviceK151017 JMS Harmony A.V. Fistula Needle SetJMS North America Corporation · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K030479 | JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle Set | Jms North America Corp. | 2003 | — |
| −4 | K051814 | JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle Set | Jms North America Corp. | 2005 | — |
| −3 | K070234 | JMS Sysloc Mini Avf and Apheresis Needle Sets | Jms North America Corp. | 2007 | — |
| −2 | K082882 | A.V. Fistula Blunt Needle Set | Jms North America Corp. | 2009 | — |
| −1 | K093637 | JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300… | Jms North America Corp. | 2010 | — |
| 0 (this device) | K151017 | JMS Harmony A.V. Fistula Needle Set | JMS North America Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K093637 | JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300…Summary page 4…Fistula Needle Set Classification : Class II Product Code : FIE Code of Federal Regulations: 21CFR876.5540 Predicate Device [807.92(a)(3)] K Number Product Company K093637 JMS Blunt A.V.Fistula Needle JMS North America Set with Site Preparation Tool Corporation K990470 JMS A.V.Fistula Needle Set IMS… | 2010 |
| * | K990470 | JMS a. V. Fistula Needle SetSummary page 4…FR876.5540 Predicate Device [807.92(a)(3)] K Number Product Company K093637 JMS Blunt A.V.Fistula Needle JMS North America Set with Site Preparation Tool Corporation K990470 JMS A.V.Fistula Needle Set IMS Co., Ltd Device Description [807.92(a)(4)] JMS Harmony® A.V. Fistula Needle Set, the modified de… | 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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 10 ancestors have 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. 2015, 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?
JMS Harmony® A.V.Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment and for the removal of scabs that have developed over the constant site prior to cannulation. The device is intended for single use only and is used on ‘developed constant site’ access sites. This device is for use on developed ‘constant site’ access sites
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151017: JMS Harmony A.V. Fistula Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151017
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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