510(k) Report

510(k) · Cleared

Cleared

TFX Medical Safety Needle with Introducer

K000665510(k) AbbreviatedCleared May 2, 200064-day reviewClass II21 CFR 880.5200

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

Tfx Medical, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on May 2, 2000 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided
May 2, 2000
Review
64 days
Class
Class II
Product code
FOZ
Recalls
None
Predicates
0

8 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2002: 3 descendants cleared2004: 2 descendants cleared2007: 1 descendant cleared2018: 1 descendant cleared2021: 1 descendant cleared200020052010201520202025
  1. This deviceK000665 TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2000
  2. Descendant · cites it directly · 4 of its ownK021034 Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002
  3. Descendant · cites it directly · 3 of its ownK043258 Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical · 2004
  4. Descendant · 2 generations on · 1 of its ownK070449 Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007
  5. Descendant · 2 generations on · 0 of its ownK211072 Safety Trocar CannulaBoston Scientific Corporation · 2021
  6. Descendant · 2 generations on · 0 of its ownK180725 Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2002: 32004: 22007: 12018: 12021: 1
2002high 3 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 8 · See all
  • K021034Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002 · cites it directly4descendants
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000665TFX Medical Safety Needle with IntroducerTfx Medical, Inc.2000—
+1K021034Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc.2002—
+1K043258Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical2004—
+2K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc.2007—
+2K211072Safety Trocar CannulaBoston Scientific Corporation2021—
+2K180725Aspire Introducer NeedleAspire Bariatrics, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200420
200710
201810
202110
FIG. 1 — Lineage of K000665, 2000–2021Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FOZ? 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 FOZ device

  1. #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021034Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc.20024
K043258Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical20043
K041708Enpath Safety IntroducerEnpath Medical Incorporated20040
K022099Safe-T-Peel Safety Needle/Introducer, Models 350-300 S, 360-300'S,380-300'S,390-300'SHdc Corp.20020
K020985Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc.20020

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?

  • Of its descendants, K021034 (Tfx Medical, Inc., 2002) has gone furthest, with 4 descendants of its own.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FOZ

11in 2025

2007: 62008: 92009: 92010: 32011: 62012: 132013: 42014: 92015: 102016: 92017: 92018: 12019: 82020: 102021: 42022: 82023: 92024: 62025: 112026 (partial year): 7
2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007: 159 days median2008: 103 days median2009: 30 days median2010: 28 days median2011: 132 days median2012: 122 days median2013: 104 days median2014: 99 days median2015: 107 days median2016: 63 days median2017: 51 days median2019: 140 days median2020: 191 days median2021: 242 days median2022: 183 days median2023: 129 days median2024: 190 days median2025: 91 days median2026 (partial year): 203 days median
2007high 242 (2021) · low 28 (2010)2026

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

Recalls per year · FOZ

4in 2023

2007: 162009: 232010: 1152013: 22014: 42016: 3, 1 Class I2017: 222018: 42019: 32020: 32021: 12022: 4, 2 Class I2023: 4, 2 Class I2026 (partial year): 2
2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007: 3742008: 4222009: 5082010: 3702011: 7862012: 5602013: 6402014: 8152015: 7292016: 9252017: 1,9662018: 3,3052019: 4,3652020: 3,7972021: 4,6742022: 4,1332023: 4,4302024: 4,7722025: 5,110
2007high 5,110 (2025) · low 370 (2010)2025

MAUDE reports naming product code FOZ, 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
2007615916374
200891030422
200993023508
2010328115370
201161320786
2012131220560
201341042640
20149994815
2015101070729
20169633 (1)925
2017951221,966
20181—43,305
2019814034,365
20201019133,797
2021424214,674
202281834 (2)4,133
202391294 (2)4,430
2024619004,772
2025119105,110
202672032—

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
  • K020985Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002
  • K993191TFX Medical Introducer AssemblyTfx Medical, Inc. · 2000

Recent decisions in FOZ

The FOZ category page

  • K260432Ruby Intravascular CatheterVenocare, Inc. · 2026
  • K260165Unimpregnated Central Venous CatheterSpectrum Vascular · 2026
  • K261041ClearSafe Closed SystemMedSource Labs, LLC · 2026
  • K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC · 2026
  • K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc. · 2026

https://510kreport.com/device/K000665 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000665: TFX Medical Safety Needle with Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000665

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026