510(k) Report

510(k) · Cleared

Cleared

Modified TFX Medical Safety Needle with Introducer

K020985510(k) TraditionalCleared Jun 25, 200290-day reviewClass II21 CFR 876.5980

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tfx Medical, Inc. · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Jun 25, 2002 as substantially equivalent to K851140 (Teleflexmedical, Inc., 1985) and 4 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1985.

Decided
Jun 25, 2002
Review
90 days
Class
Class II
Product code
KNT
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K851140 (1985). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestorK851140 · Teleflex Medical Introducer Needle · Teleflexmedical, Inc. · 19851985199019952000
Other ancestors, by generation 1 generation back: 4 other ancestors K851140 · Teleflex Medical Introducer Needle · Teleflexmedical, Inc. · 19850
  1. Root · 1 generation backK851140 Teleflex Medical Introducer NeedleTeleflexmedical, Inc. · 1985
  2. This deviceK020985 Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K851140Teleflex Medical Introducer NeedleTeleflexmedical, Inc.1985—
0 (this device)K020985Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199110
199210
200010
FIG. 1 — Lineage of K020985, 1985–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.8 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K851140Teleflex Medical Introducer Needle
Summary page 1
…d TFX Medical Safety Needle with Introducer is substantially equivalent in design and materials to: The TFX Medical Introducer Needle - K851140 The PUNCTUR-GUARD Blood Collection Needle of Bio-Plexus, Inc, for the activation mechanism…
Teleflexmedical, Inc.1985—
*K895024Punctur-Guard (TM) Blood Collection Needle
Our reading of the summary gave K895034, FDA’s number for Buckys Models Ymb-15A, Ymb-15B and Ymb-15C (Yamato Medical Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “The PUNCTUR-GUARD Blood Collection Needle of Bio-Plexus, Inc.”.
Bio-Plexus, Inc.1990—
*K912047Wilson-Cook Russell Gastrostomy Kit
Summary page 1
…UARD Blood Collection Needle of Bio-Plexus, Inc, for the activation mechanism - K895034 The COOK8 OB/GYN Russell Gastrostomy Tray - K912047 TFX Medical, Inc. Over-the-Needle Splitable Catheter Assembly, Type I - K920908 === Page 2…
Wilson-Cook Medical, Inc.1991—
*K920908Over the Needle Splitable Catheter Assembly Type 1
Summary page 1
…The COOK8 OB/GYN Russell Gastrostomy Tray - K912047 TFX Medical, Inc. Over-the-Needle Splitable Catheter Assembly, Type I - K920908 Page 2 The TFX Medical Safety Needle with Introducer - KO00665 0 The COOK8 Gastric Port S…
Teleflexmedical, Inc.1992—
*K000665TFX Medical Safety Needle with Introducer
Summary page 2
…i o n of the D e v i c e : 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 availabl…
Tfx Medical, Inc.2000—
*—The COOK8 Gastric Port System
Named without a submission number
—
*—The COOK8 Edelman Gastrostomy Tray
Named without a submission number
—

Also cleared against K851140: 3 other devices →

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?

  • None of the 5 ancestors has a recall.
  • 3 other devices also cite its predicate K851140.

How does its category compare?

All KNT devices

KNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNT

4in 2025

2007: 102008: 102009: 112010: 122011: 72012: 122013: 72014: 162015: 102016: 62017: 92018: 72019: 102020: 52021: 62022: 72023: 52024: 92025: 42026 (partial year): 3
2007high 16 (2014) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNT

136in 2025

2007: 118 days median2008: 115 days median2009: 102 days median2010: 104 days median2011: 211 days median2012: 107 days median2013: 128 days median2014: 259 days median2015: 140 days median2016: 99 days median2017: 247 days median2018: 149 days median2019: 126 days median2020: 102 days median2021: 121 days median2022: 110 days median2023: 162 days median2024: 103 days median2025: 136 days median2026 (partial year): 105 days median
2007high 259 (2014) · low 99 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNT

13in 2025

2007: 12008: 822009: 92010: 32011: 22012: 12015: 12016: 32017: 42018: 22019: 22020: 12021: 22022: 1, 1 Class I2023: 22025: 132026 (partial year): 20
2007high 82 (2008) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KNT

1,451in 2025

2007: 3002008: 8672009: 8182010: 5172011: 5312012: 5282013: 7472014: 1,0302015: 1,0482016: 1,2512017: 1,6722018: 1,9012019: 1,8382020: 1,6412021: 1,6552022: 1,6502023: 1,8632024: 1,3442025: 1,451
2007high 1,901 (2018) · low 300 (2007)2025

MAUDE reports naming product code KNT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007101181300
20081011582867
2009111029818
2010121043517
201172112531
2012121071528
201371280747
20141625901,030
20151014011,048
201669931,251
2017924741,672
2018714921,901
20191012621,838
2020510211,641
2021612121,655
202271101 (1)1,650
2023516221,863
2024910301,344
20254136131,451
2026310520—

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.

Also cleared against K851140

3 other devices cite the same predicate.

  • K082580Spectra Guidewire Introducer NeedleSpectra Medical Devices, Inc. · 2008
  • K043258Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical · 2004
  • K021034Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002

More from Tfx Medical, Inc.

4 FDA decisions under this applicant name. See the company

  • K021034Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002
  • K000665TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2000
  • K993191TFX Medical Introducer AssemblyTfx Medical, Inc. · 2000

Recent decisions in KNT

The KNT category page

  • K262038danumed StomaMeterDanumed Medizintechnik GmbH · 2026
  • K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2025
  • K243228Flexi-Seal AIR (with ENFit Connector)Convatec · 2025

https://510kreport.com/device/K020985 · printed Nov 3, 2026

Cite this page

510(k) Report. “K020985: Modified TFX Medical Safety Needle with Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020985

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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