510(k) Report

FDA applicant

Shinchang Medical Co., Ltd.

Salt Lake City, UT3 decisions2000–20078 recalls

FDA records 3 decisions for Shinchang Medical Co., Ltd. (Salt Lake City, UT) from 2000 to 2007: 3 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 2 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 Shinchang Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2018

2009: 62018: 2
2007high 6 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Shinchang Medical Co., Ltd.’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?

  • FMFSyringe, Piston1decision
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision
  • FMINeedle, Hypodermic, Single Lumen1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K993017Profi Disposable Syringe, Profi Disposable Needle, DM Ject Insulin SyringeShinchang Medical Co., Ltd. · 20001cites it

What has FDA decided for it lately?

  • K071382SCM Cath ( Sizes Are Varying Between 16G X 2'' and 24G X 3/4'' ), Model 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,Shinchang Medical Co., Ltd. · 2007
  • K070988SC Profi Fine Pen Needle, Models; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)Shinchang Medical Co., Ltd. · 2007
  • K993017Profi Disposable Syringe, Profi Disposable Needle, DM Ject Insulin SyringeShinchang Medical Co., Ltd. · 20008 recalls

All 3 as Shinchang Medical Co., Ltd. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K993017McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage…Sep 4, 2018Class II
  • K993017Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16.…Aug 24, 2018Class II
  • K021197AccuSure, U-100 30 Gauge, 1/2cc 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