510(k) · Cleared
ClearedModified TFX Medical Safety Needle with Introducer, Part NO. T4634-02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Dec 16, 2004 as substantially equivalent to K851140 (Teleflexmedical, Inc., 1985) and 3 other predicates after a 22-day review. Its family tree reaches back 2 generations to 1985. 3 later devices descend from it.
- Decided
- Dec 16, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K851140 (1985). 6 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK851140 Teleflex Medical Introducer NeedleTeleflexmedical, Inc. · 1985
- 1 generation backK021034 Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002
- This deviceK043258 Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical · 2004
- Descendant · cites it directly · 1 of its ownK070449 Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK211072 Safety Trocar CannulaBoston Scientific Corporation · 2021
- Descendant · cites it directly · 0 of its ownK180725 Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007 · cites it directly1descendant
- K211072Safety Trocar CannulaBoston Scientific Corporation · 2021 · cites it directly0descendants
- K180725Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851140 | Teleflex Medical Introducer Needle | Teleflexmedical, Inc. | 1985 | — |
| −1 | K021034 | Modified TFX Medical Safety Needle with Introducer | Tfx Medical, Inc. | 2002 | — |
| 0 (this device) | K043258 | Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02 | Teleflex Medical | 2004 | — |
| +1 | K070449 | Lumiloc (TM) Safety Introducer Needle | Specialized Health Products International, Inc. | 2007 | — |
| +1 | K211072 | Safety Trocar Cannula | Boston Scientific Corporation | 2021 | — |
| +1 | K180725 | Aspire Introducer Needle | Aspire Bariatrics, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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? (4)
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 |
|---|---|---|---|
| * | K851140 | Teleflex Medical Introducer NeedleSummary page 3…November 16, 2004 ~ Special 510(k) Submission: Modified TFX Medical Safety Needle with Introducer * The TFX Medical Introducer Needle -- K851140 · The PUNCTUR-GUARD Blood Collection Needle of Bio-Plexus, Inc, for the activation mechanism - K895024… | 1985 |
| * | K895024 | Punctur-Guard (TM) Blood Collection NeedleSummary page 2…Passive Sharps Protection)- The Safety Needle, has the same blunter technology as the Bio-Plexus, Punctur-Guard Blood Collection needle (K895024). 2. Sheath Introducer- The functionality of the peelable, splitable introducer is identical to the… | 1990 |
| * | K000665 | TFX Medical Safety Needle with IntroducerSummary page 3…The PUNCTUR-GUARD Blood Collection Needle of Bio-Plexus, Inc, for the activation mechanism - K895024 * The TFX Medical Safety Needle with Introducer - K000665 * The Modified TFX Medical Safety Needle with Introducer-K021034 2. Summary of Technological Characteristics:… | 2000 |
| * | K021034 | Modified TFX Medical Safety Needle with IntroducerSummary page 2…ded Use of the Modified Safety Needle with Introducer device is identical to the Modified TFX Medical Safety Needle with Introducer cleared by the FDA in K021034. In order to provide a more robust design, the material of construction has been changed from High Density Polyethylene t… | 2002 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 3 companies; a new generation was cleared every 17.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K070449 (Specialized Health Products International, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K851140.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Modified TFX Medical Safety Needle with Introducer is intended to be used for guidewire introduction during gastrointestinal procedures such as PEG (Percutaneous Endoscopic Gastrostomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043258: Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043258
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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