510(k) · Cleared
Recalled · Class II · 2012Medisystems Buttonhole Needle Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisystems Corp. · FIE Needle, Fistula
Cleared on Jan 6, 2000 as substantially equivalent to K823068 (Medisystems Corp., 1983) and 1 other predicate after a 302-day review. Its family tree reaches back 1 generation to 1983. 6 later devices descend from it. It has been recalled once.
- Decided
- Jan 6, 2000
- Review
- 302 days
- Class
- Class II
- Product code
- FIE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K823068 (1983). 2 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK823068 Medisystems Fistula NeedlesMedisystems Corp. · 1983
- This deviceK990803 Medisystems Buttonhole Needle SetsMedisystems Corp. · 2000
- Descendant · cites it directly · 2 of its ownK082882 A.V. Fistula Blunt Needle SetJms North America Corp. · 2009
- Descendant · 2 generations on · 1 of its ownK093637 JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model…Jms North America Corp. · 2010
- Descendant · 3 generations on · 0 of its ownK151017 JMS Harmony A.V. Fistula Needle SetJMS North America Corporation · 2015
- Descendant · cites it directly · 0 of its ownK134019 Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick…Nxstage Medical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK130873 Vwing Vascular Needle Guide, 4MM X 07MM; Vwing Vascular Needle…Vital Access · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K082882A.V. Fistula Blunt Needle SetJms North America Corp. · 2009 · cites it directly2descendants
- K093637JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300…Jms North America Corp. · 2010 · 2 generations on1descendant
- K151017JMS Harmony A.V. Fistula Needle SetJMS North America Corporation · 2015 · 3 generations on0descendants
- K134019Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle Protector…Nxstage Medical, Inc. · 2014 · cites it directly0descendants
- K130873Vwing Vascular Needle Guide, 4MM X 07MM; Vwing Vascular Needle Guide, 6MM X 07MM; Vwing…Vital Access · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K823068 | Medisystems Fistula Needles | Medisystems Corp. | 1983 | — |
| 0 (this device) | K990803 | Medisystems Buttonhole Needle Sets | Medisystems Corp. | 2000 | — |
| +1 | K082882 | A.V. Fistula Blunt Needle Set | Jms North America Corp. | 2009 | — |
| +2 | K093637 | JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300… | Jms North America Corp. | 2010 | — |
| +3 | K151017 | JMS Harmony A.V. Fistula Needle Set | JMS North America Corporation | 2015 | — |
| +1 | K134019 | Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle… | Nxstage Medical, Inc. | 2014 | — |
| +1 | K130873 | Vwing Vascular Needle Guide, 4MM X 07MM; Vwing Vascular Needle Guide, 6MM X… | Vital Access | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K823068 | Medisystems Fistula NeedlesSummary page 1…aimed: The Medisystems Buttonhole Needle Sets that are the subject of this submission are substantially equivalent to Needle Sets described by Medisystems’ 510(k) number K823068 for Medisystems Arterial Venous Fistula Needles in terms of their design and materials of construction and Becton-Dickinson’s 510… | 1983 |
| * | K951254 | Safetyglide NeedleSummary page 1…ystems’ 510(k) number K823068 for Medisystems Arterial Venous Fistula Needles in terms of their design and materials of construction and Becton-Dickinson’s 510(k) number K951254 for Hypodermic Needles in terms of their indications for use. VII. Product Description: The Medisystems Buttonhole Needle Set co… | 1995 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2012 | Class II | Z-0714-2013 | Labeling mix-ups | A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5". |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K082882 (Jms North America Corp., 2009) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site or “buttonhole™ method of needle insertion.
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/K990803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990803: Medisystems Buttonhole 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/K990803
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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