510(k) · Cleared
ClearedNipro Safetouch Locktail Safety Fistula Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corp. · FIE Needle, Fistula
Cleared on Jan 22, 2010 as substantially equivalent to K032777 (Nipro Medical Corp., 2003) after a 29-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jan 22, 2010
- Review
- 29 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002813 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK002813 Nipro Safetouch Safety Fistula NeedleNipro Medical Corp. · 2000 · Recalled
- 1 generation backK032777 Modification to: Nipro Safe Touch Safety Fistula NeedleNipro Medical Corp. · 2003 · Recalled
- This deviceK093985 Nipro Safetouch Locktail Safety Fistula NeedleNipro Medical Corp. · 2010
View FIG. 1 as a table
Line of descent and top descendants
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? (1)
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 |
|---|---|---|---|
| * | K032777 | Modification to: Nipro Safe Touch Safety Fistula NeedleSummary page 1…cessories Regulation Number: 21 CFR 876.5540 Panel: 78 Product code: FIE 807.92(a)(3) Legally marketed substantial equivalent device: K032777 - NIPRO SafeTouch 11Safety AVF Needle 807.92(a)(4) Description of device: The NIPRO SafeTouch LockTa ilTM Safety F… | 2003 |
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 10 years and passes through 1 company; a new generation was cleared every 6.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K032777.
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Nipro SafeTouch LOCKTAILTM is intended for use as a blood access device for blood
purification and for other treatments requiring extracorporeal circuit. The Nipro
SafeTouch LoCKTAIL Tm aids in the prevention of accidental needle stick injuries. The
compatibility of available configurations is the responsibility of the physician in charge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093985: Nipro Safetouch Locktail Safety Fistula Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093985
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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