510(k) · Cleared
ClearedMedisystems Apheresis Needle with Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisystems Corp. · FIE Needle, Fistula
Cleared on Feb 18, 1994 after a 296-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Feb 18, 1994
- Review
- 296 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK932074 Medisystems Apheresis Needle with GuardMedisystems Corp. · 1994
- Descendant · cites it directly · 3 of its ownK071145 Nipro Safetouch Tulip Safety Fistula NeedleNipro Medical Corporation · 2007 · Recalled
- Descendant · cites it directly · 2 of its ownK073257 Kawasumi Laboratories Large Wing Sets with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK163025 DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK102994 K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK213015 DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K071145Nipro Safetouch Tulip Safety Fistula NeedleNipro Medical Corporation · 2007 · cites it directly3descendants
- K073257Kawasumi Laboratories Large Wing Sets with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2008 · cites it directly2descendants
- K163025DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. · 2017 · 2 generations on1descendant
- K102994K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2010 · cites it directly1descendant
- K213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932074 | Medisystems Apheresis Needle with Guard | Medisystems Corp. | 1994 | — |
| +1 | K071145 | Nipro Safetouch Tulip Safety Fistula Needle | Nipro Medical Corporation | 2007 | 1 |
| +1 | K073257 | Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector | Kawasumi Laboratories, Inc. | 2008 | — |
| +2 | K163025 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017 | — |
| +1 | K102994 | K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector | Kawasumi Laboratories, Inc. | 2010 | — |
| +3 | K213015 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071145 | Nipro Safetouch Tulip Safety Fistula Needle | 2007 | 3 |
| K073257 | Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector | 2008 | 2 |
| K102994 | K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector | 2010 | 1 |
| K991404 | Platypus AV Fistula Needle Protector (Avfnp) | 1999 | 0 |
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, K071145 (Nipro Medical Corporation, 2007) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K932074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K932074: Medisystems Apheresis Needle with Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932074
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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