510(k) · Cleared
ClearedSafety Trocar Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Apr 27, 2021 as substantially equivalent to K043258 (Teleflex Medical, 2004) after a 15-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Apr 27, 2021
- Review
- 15 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K851140 (1985). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK851140 Teleflex Medical Introducer NeedleTeleflexmedical, Inc. · 1985
- 2 generations backK021034 Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002
- 1 generation backK043258 Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical · 2004
- This deviceK211072 Safety Trocar CannulaBoston Scientific Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K851140 | Teleflex Medical Introducer Needle | Teleflexmedical, Inc. | 1985 | — |
| −2 | 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 | — |
| 0 (this device) | K211072 | Safety Trocar Cannula | Boston Scientific Corporation | 2021 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K043258 | Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Summary page 4…oducer Classification Name: Gastrointestional Tube and Accessories Regulation Number: 21CFR §876.5980 Product code: KNT Classification: Class II 510(k) Clearance Number: K043258 4. Device Description: The Safety Trocar Cannula is a sterile, single use needle used for guidewire introduction during a gastr… | 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 36 years and passes through 4 companies; a new generation was cleared every 16.4 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K043258.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Safety Trocar Cannula is intended to be used for guidewire introduction during gastrointestinal procedures such as PEG (percutaneous Endoscopic Gastrotomy), 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/K211072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211072: Safety Trocar Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211072
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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