510(k) Report

FDA applicant

Gri Medical & Electrical Technology Co., Ltd.

Jiaxing, CN3 decisions2016–20170 recalls

FDA records 3 decisions for Gri Medical & Electrical Technology Co., Ltd. (Jiaxing, CN) from 2016 to 2017: 3 510(k) clearances. All are in product code FYA (Gown, Surgical). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. No 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 and plastic surgery panel, where it files most

How often FDA has decided Gri Medical & Electrical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2016: 12017: 2
2016high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Gri Medical & Electrical Technology Co., Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FYAGown, Surgical3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 105 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. · 20161cites it
  • K163191ComfortGuard Surgical Gown, i600, Film ReinforcedGri Medical & Electrical Technology Co., Ltd. · 20171cites it

What has FDA decided for it lately?

  • K172445RoyalGuard Surgical Gown, i600, BreathableGri Medical & Electrical Technology Co., Ltd. · 2017
  • K163191ComfortGuard Surgical Gown, i600, Film ReinforcedGri Medical & Electrical Technology Co., Ltd. · 2017
  • K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. · 2016

All 3 as Gri Medical & Electrical Technology Co., Ltd. →