510(k) · Cleared
ClearedMedisystems Arterial-Venous Fistula Needle Set with Securement Device
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 12, 2007 as substantially equivalent to K941850 (Tnt Moborg Intl., Ltd., 1994) and 1 other predicate after a 136-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Feb 12, 2007
- Review
- 136 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K941850 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK941850 Immobile Non-Sterile and Immobile a/C Non-SterileTnt Moborg Intl., Ltd. · 1994
- This deviceK062953 Medisystems Arterial-Venous Fistula Needle Set with Securement DeviceMedisystems Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941850 | Immobile Non-Sterile and Immobile a/C Non-Sterile | Tnt Moborg Intl., Ltd. | 1994 | — |
| 0 (this device) | K062953 | Medisystems Arterial-Venous Fistula Needle Set with Securement Device | Medisystems Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K941850 | Immobile Non-Sterile and Immobile a/C Non-SterileSummary page 3…substantially equivalent to the SiteGuard securement device are as follows: TNT Moborg Intl., LTD, Immobile Non-sterile and Immobile A/C non-sterile (K941850); and, * TNT Immobile sterile and Immobile A/C sterile (K941940). This 5 10(k) has been supplemented with the Imm… | 1994 |
| * | K941940 | Immobile Sterile and Immobile a/C SterileSummary page 3…lows: TNT Moborg Intl., LTD, Immobile Non-sterile and Immobile A/C non-sterile (K941850); and, * TNT Immobile sterile and Immobile A/C sterile (K941940). This 5 10(k) has been supplemented with the Immobile FST product, which is designed to provide fistula access… | 1994 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Medisystems Hemodialysis Fistula Needle Securement Device,
SiteGuard, is intended for use to secure the fistula needle to the patient's skin.
The SiteGuard needle securement device has the following features:
a. It allows the needle to be held at a consistent angle during treatment;
b. It secures wing/hub to the patient's skin and helps prevent movement
and/or dislodgement of the needle during use; and,
c. It helps to immobilize the patient's vein or access during cannulation so
that it is not necessary for caregivers to hold the vein or access with their
fingers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062953 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062953: Medisystems Arterial-Venous Fistula Needle Set with Securement Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062953
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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