510(k) Report

FDA applicant

Retractable Technologies, Inc.

Little Elm, TX13 decisions1995–20211 recall

FDA records 13 decisions for Retractable Technologies, Inc. (Little Elm, TX) from 1995 to 2021: 13 510(k) clearances. Most are in product codes MEG (Syringe, Antistick) and FMF (Syringe, Piston). Its devices cite 9 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Retractable Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 12008: 12011: 22013: 12014: 12021: 1
2007high 2 (2011) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Retractable Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Retractable Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MEGSyringe, Antistick4decisions
  • FMFSyringe, Piston2decisions
  • FMINeedle, Hypodermic, Single Lumen2decisions
  • JKATubes, Vials, Systems, Serum Separators, Blood Collection2decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2decisions
  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 9 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K946219Pop-N-Lok SyringeRetractable Technologies, Inc. · 19955cite it
  • K980069Vanishpoint SyringeRetractable Technologies, Inc. · 19984cite it
  • K971763Blood Collection Tube Holder Vanishpoint Tube Holder/Small Tube AdapterRetractable Technologies, Inc. · 19972cite it
  • K051355Vanishpoint I.V. CatheterRetractable Technologies, Inc. · 20052cite it
  • K970803Anti-Stick Syringe with Integral Hypodermic Needle Vanishpoint SyringeRetractable Technologies, Inc. · 19972cite it
  • K112512Vanishpoint Blood Collection SetRetractable Technologies, Inc. · 20111cites it

What has FDA decided for it lately?

  • K202325EasyPoint Blood Collection PlusRetractable Technologies, Inc. · 2021
  • K133635Easypoint NeedleRetractable Technologies, Inc. · 20141 recall
  • K122355Vanishpoint Blood Collection SetRetractable Technologies, Inc. · 2013
  • K112512Vanishpoint Blood Collection SetRetractable Technologies, Inc. · 2011
  • K101708Patient Safe Luer CapRetractable Technologies, Inc. · 2011
  • K081420Vanishpoint I.V. CatheterRetractable Technologies, Inc. · 2008
  • K072654Patient Safe SyringeRetractable Technologies, Inc. · 2007
  • K051355Vanishpoint I.V. CatheterRetractable Technologies, Inc. · 2005

All 13 as Retractable Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K133635EasyPoint Needle, 25G x 5/8", REF: 82091Feb 5, 2024Class II