510(k) · Cleared
ClearedAspire Introducer Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aspire Bariatrics, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jul 11, 2018 as substantially equivalent to K070449 (Specialized Health Products International, Inc., 2007) and 1 other predicate after a 113-day review. Its family tree reaches back 6 generations to 1980.
- Decided
- Jul 11, 2018
- Review
- 113 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K801941 (1980). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
- 5 generations backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
- 4 generations backK021094 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
- 3 generations backK030135 Safety Introducer NeedleB.Braun Medical, Inc. · 2003
- 2 generations backK050023 Secureloc; AdvancintroducerSpecialized Health Products, Inc. · 2005
- 1 generation backK070449 Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007
- This deviceK180725 Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K801941 | Burron Microcath Intra. Cath. Placementt | Burron Medical Products, Inc. | 1980 | — |
| −5 | K982805 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 1999 | 1 |
| −4 | K021094 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2002 | 1 |
| −3 | K030135 | Safety Introducer Needle | B.Braun Medical, Inc. | 2003 | — |
| −2 | K050023 | Secureloc; Advancintroducer | Specialized Health Products, Inc. | 2005 | — |
| −1 | K070449 | Lumiloc (TM) Safety Introducer Needle | Specialized Health Products International, Inc. | 2007 | — |
| 0 (this device) | K180725 | Aspire Introducer Needle | Aspire Bariatrics, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 2 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 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 KNT? 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 KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 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 |
|---|---|---|---|
| * | K070449 | Lumiloc (TM) Safety Introducer NeedleSummary page 4…uct Code: KNT Regulatory Class: II Review Panel: Gastroenterology and Urology Common Name: Introducer Needle Predicate Devices: K070449 Specialized Health Products, LumiLoc Safety Introducer Needle K043258 Teleflex Medical, TFX Medical Safet… | 2007 |
| * | K043258 | Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Summary page 4…d Urology Common Name: Introducer Needle Predicate Devices: K070449 Specialized Health Products, LumiLoc Safety Introducer Needle K043258 Teleflex Medical, TFX Medical Safety Needle with Introducer Device Description: The Aspire Introducer Needle is a single use,… | 2004 |
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 38 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 17 ancestors have a recall of any class.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, 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 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
The Aspire Introducer Needle is intended to be used for guidewire introduction during percutancous gastrointestinal procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180725 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180725: Aspire Introducer Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180725
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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