510(k) Report

FDA applicant

Feel Tech

Deer Field, IL3 decisions2007–20108 recalls

FDA records 3 decisions for Feel Tech (Deer Field, IL) from 2007 to 2010: 3 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FMF (Syringe, Piston). Its devices cite 3 predicates, 0 of them its own earlier devices. 8 recalls are 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 Feel Tech’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 12008: 12010: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

8in 2009

2009: 8
2007high 8 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen2decisions
  • FMFSyringe, Piston1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 0 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.

  • K080904Feel-Fine Insulin Pen NeedleFeel Tech · 20088cite it
  • K070917Feel-Ject Insulin SyringeFeel Tech · 20075cite it

What has FDA decided for it lately?

  • K092831Disposable Hypodermic NeedleFeel Tech · 2010
  • K080904Feel-Fine Insulin Pen NeedleFeel Tech · 20087 recalls
  • K070917Feel-Ject Insulin SyringeFeel Tech · 20071 recall

All 3 as Feel Tech →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K021197AccuSure, U-100 30 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle…Oct 27, 2009
  • K021197AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle…Oct 27, 2009
  • K021197AccuSure, U-100 28 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10…Oct 27, 2009
  • K021197AccuSure, U-100 29 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10…Oct 27, 2009
  • K021197AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle…Oct 27, 2009
  • K021197AccuSure, U-100 28 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10…Oct 27, 2009