510(k) Report

FDA applicant

Safe Secure Packaging Co., Ltd.

Shenzhen, CN2 decisions2012–201643 recalls

FDA records 2 decisions for Safe Secure Packaging Co., Ltd. (Shenzhen, CN) from 2012 to 2016: 2 510(k) clearances. All are in product code FRG (Wrap, Sterilization). Its devices cite 3 predicates, 1 of them its own earlier devices. 43 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 Safe Secure Packaging Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2012: 12016: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

14in 2020

2017: 292020: 14
2012high 29 (2017) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Safe Secure Packaging Co., Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Safe Secure Packaging 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?

  • FRGWrap, Sterilization2decisions

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 5 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.

  • K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. · 20163cite it
  • K112591Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. · 20122cite it

What has FDA decided for it lately?

  • K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. · 201643 recalls
  • K112591Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. · 2012

All 2 as Safe Secure Packaging Co., Ltd. →

What has been recalled?

43 recalls linked to its devices; the latest:

  • K153540Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10…Dec 2, 2020Class II
  • K153540Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model…Dec 2, 2020Class II
  • K153540Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model…Dec 2, 2020Class II
  • K153540Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model…Dec 2, 2020Class II
  • K153540Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10…Dec 2, 2020Class II
  • K153540Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model…Dec 2, 2020Class II

Other applicant names beginning “Safe”

FDA records each applicant name separately; these may or may not be the same firm.

Safe Orthopaedics 13Safe Shield Co., Ltd. 2Safe Tech Medical Products, Inc. 2Safe-Tec Clinical Products, Inc. 2Safe Glove, Ltd. 2Safe Obstetric Systems, Ltd. 1Safe Product Supplies 1Safe T Medical Devices, Ltd. 1Safe Secure Packing Co., Ltd. 1Safe Restraints, Inc. 1Safe Sun Corporation of America, Inc. 1Safe Bvm Corporation 1