510(k) · Cleared
ClearedModified TFX Medical Safety Needle with Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tfx Medical, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jun 26, 2002 as substantially equivalent to K851140 (Teleflexmedical, Inc., 1985) and 3 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1985. 4 later devices descend from it.
- Decided
- Jun 26, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K851140 (1985). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK851140 Teleflex Medical Introducer NeedleTeleflexmedical, Inc. · 1985
- This deviceK021034 Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK043258 Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical · 2004
- Descendant · 2 generations on · 1 of its ownK070449 Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK211072 Safety Trocar CannulaBoston Scientific Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK180725 Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K043258Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical · 2004 · cites it directly3descendants
- K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007 · 2 generations on1descendant
- K211072Safety Trocar CannulaBoston Scientific Corporation · 2021 · 2 generations on0descendants
- K180725Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851140 | Teleflex Medical Introducer Needle | Teleflexmedical, Inc. | 1985 | — |
| 0 (this device) | K021034 | Modified TFX Medical Safety Needle with Introducer | Tfx Medical, Inc. | 2002 | — |
| +1 | K043258 | Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02 | Teleflex Medical | 2004 | — |
| +2 | K070449 | Lumiloc (TM) Safety Introducer Needle | Specialized Health Products International, Inc. | 2007 | — |
| +2 | K211072 | Safety Trocar Cannula | Boston Scientific Corporation | 2021 | — |
| +2 | K180725 | Aspire Introducer Needle | Aspire Bariatrics, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K851140 | Teleflex Medical Introducer NeedleSummary page 1…TFX Medical Safety Needle with Introducer is substantially equivalent in design and materials to: Q The TFX Medical Introducer Needle - K851140 = The PUNCTUR-GUARD Blood Collection Needle of Bio-Plexus, Inc, for the activation mechanism - K… | 1985 |
| Kept off the family tree | K895034 | FDA’s K895034 is Buckys Models Ymb-15A, Ymb-15B and Ymb-15C Our reading of the summary gave K895034, FDA’s number for Buckys Models Ymb-15A, Ymb-15B and Ymb-15C (Yamato Medical Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “PUNCTUR-GUARD Blood Collection Needle”. Kept off the family tree. Summary page 1…e TFX Medical Introducer Needle - K851140 = The PUNCTUR-GUARD Blood Collection Needle of Bio-Plexus, Inc, for the activation mechanism - K895034 0 The COOK8 OB/GYN Russell Gastrostomy Tray - K912047 TFX Medical. Inc. Over-the-Needle Split… | 1989 |
| * | K912047 | Wilson-Cook Russell Gastrostomy KitSummary page 1…UARD Blood Collection Needle of Bio-Plexus, Inc, for the activation mechanism - K895034 0 The COOK8 OB/GYN Russell Gastrostomy Tray - K912047 TFX Medical. Inc. Over-the-Needle Splitable Catheter Tall Pines P a r k Jaffrey, NH 034!j$ssemb1y! Type I -… | 1991 |
| * | K920908 | Over the Needle Splitable Catheter Assembly Type 1Summary page 2…2, Peelable Splitable Introducer- This introducer is identical to the existing introducer sold by TFX Medical, which was cleared under K920908. 5. Intended Use of the Device: The TFX Medical Safety Needle with Introducer is intended to be u… | 1992 |
| * | K000665 | TFX Medical Safety Needle with IntroducerSummary page 2…f the Device: This device, with the exception of '-length,is identical to the TFX Medical Safety Needle with Introducer cleared by the FDA in K000665. The working length of the needle has been increased, due to the intended gastrointestinal use, and will be ava… | 2000 |
| * | — | COOK Gastric Port System Named without a submission number | |
| * | — | COOK Edelman Gastrostomy Tray Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043258 | Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02 | 2004 | 3 |
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?
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/K021034 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021034: Modified TFX Medical Safety Needle with Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021034
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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