510(k) · Cleared
ClearedAngel Tip Safety Intravascular Needle Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Summit International Medical Technologies, Inc. · FIE Needle, Fistula
Cleared on Jan 16, 2015 as substantially equivalent to K912563 (Mbo Laboratories, Inc., 1991) and 1 other predicate after a 568-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jan 16, 2015
- Review
- 568 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010406 (2001). 3 ancestors in all, the oldest K912563 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010406 | JMS a.V. Fistula Needle Set Wing Eater, Model 14G-18G | Jms Co., Ltd. | 2001 | — |
| −1 | K111948 | Wingeater V2 | JMS North America Corporation | 2011 | — |
| 0 (this device) | K131950 | Angel Tip Safety Intravascular Needle Set | Summit International Medical Technologies, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 |
|---|---|---|---|
| * | K912563 | Angel Wing Safety Blood Collection and Infusion SESummary page 4…scular Needle Set Common Name: Safety Intravascular Needle Set Classification Name: Needle, Fistula: per 21 CFR: 876.5540 Product code: FIE Predicate Devices • K912563: Angel Wing Safety Blood Collection and Infusion Set • K111948: A.V. Fistula Needle Set “WingEater®” Device Description T… | 1991 |
| * | K111948 | Wingeater V2Summary page 4…sification Name: Needle, Fistula: per 21 CFR: 876.5540 Product code: FIE Predicate Devices • K912563: Angel Wing Safety Blood Collection and Infusion Set • K111948: A.V. Fistula Needle Set “WingEater®” Device Description The safety needle portion of the Angel Tip Safety Intravascular Needle… | 2011 |
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 14 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K912563.
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Angel Tip Safety Intravascular Needle Set is indicated to access the peripheral vascular system for hemodialysis.
Additionally, after withdrawal of the needle from the patient's vein, the needle can be manually retracted within a safety
enclosure to minimize the risk of an accidental needle stick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131950 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131950: Angel Tip Safety Intravascular Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131950
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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