510(k) · Cleared
ClearedMedisystems Fistula Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisystems Corp. · KOC Accessories, Blood Circuit, Hemodialysis
Cleared on Jan 26, 1983 after a 99-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jan 26, 1983
- Review
- 99 days
- Class
- Class II
- Product code
- KOC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK823068 Medisystems Fistula NeedlesMedisystems Corp. · 1983
- Descendant · cites it directly · 6 of its ownK990803 Medisystems Buttonhole Needle SetsMedisystems Corp. · 2000 · Recalled
- Descendant · 2 generations on · 2 of its ownK082882 A.V. Fistula Blunt Needle SetJms North America Corp. · 2009
- Descendant · 3 generations on · 1 of its ownK093637 JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model…Jms North America Corp. · 2010
- Descendant · 4 generations on · 0 of its ownK151017 JMS Harmony A.V. Fistula Needle SetJMS North America Corporation · 2015
- Descendant · 2 generations on · 0 of its ownK134019 Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick…Nxstage Medical, Inc. · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K990803Medisystems Buttonhole Needle SetsMedisystems Corp. · 2000 · cites it directly6descendants
- K082882A.V. Fistula Blunt Needle SetJms North America Corp. · 2009 · 2 generations on2descendants
- K093637JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300…Jms North America Corp. · 2010 · 3 generations on1descendant
- K151017JMS Harmony A.V. Fistula Needle SetJMS North America Corporation · 2015 · 4 generations on0descendants
- K134019Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle Protector…Nxstage Medical, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K823068 | Medisystems Fistula Needles | Medisystems Corp. | 1983 | — |
| +1 | K990803 | Medisystems Buttonhole Needle Sets | Medisystems Corp. | 2000 | 1 |
| +2 | K082882 | A.V. Fistula Blunt Needle Set | Jms North America Corp. | 2009 | — |
| +3 | K093637 | JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300… | Jms North America Corp. | 2010 | — |
| +4 | K151017 | JMS Harmony A.V. Fistula Needle Set | JMS North America Corporation | 2015 | — |
| +2 | K134019 | Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle… | Nxstage Medical, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KOC? 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 KOC device
- #1 K230514 Blood Tubing Lines for Hemodialysis AL Series…score 11.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990803 | Medisystems Buttonhole Needle Sets | 2000 | 6 |
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?
- Of its descendants, K990803 (Medisystems Corp., 2000) has gone furthest, with 6 descendants of its own.
How does its category compare?
All KOC devicesKOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KOC
Too few KOC 510(k)s in any year since 2007 to give a median.
Recalls per year · KOC
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOC
50in 2025
MAUDE reports naming product code KOC, 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 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 2 | 12 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 22 |
| 2014 | 1 | — | 1 | 165 |
| 2015 | 2 | — | 0 | 555 |
| 2016 | 1 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 23 |
| 2018 | 0 | — | 3 | 37 |
| 2019 | 0 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 18 |
| 2025 | 2 | — | 0 | 50 |
| 2026 | 0 | — | 4 | — |
https://510kreport.com/device/K823068 · printed Nov 5, 2026
Cite this page
510(k) Report. “K823068: Medisystems Fistula Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K823068
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026