510(k) Report

FDA applicant

Sigma Medical Supplies Corp.

New Taipei City, TW5 decisions2011–20210 recalls

FDA records 5 decisions for Sigma Medical Supplies Corp. (New Taipei City, TW) from 2011 to 2021: 5 510(k) clearances. All are in product code FRG (Wrap, Sterilization). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sigma Medical Supplies Corporation”.

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 Sigma Medical Supplies Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2011: 12015: 12018: 22021: 1
2011high 2 (2018) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Sigma Medical Supplies Corp. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • FRGWrap, Sterilization5decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 84 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 150 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 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.

  • K102158Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 20115cite it
  • K180672Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corporation · 20184cite it
  • K180661SIGMA Sterilization Pouch and RollSigma Medical Supplies Corp. · 20182cite it
  • K133838Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corp. · 20151cites it

What has FDA decided for it lately?

  • K202462SIGMA Sterilization Pouch and RollSigma Medical Supplies Corporation · 2021
  • K180672Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corporation · 2018
  • K180661SIGMA Sterilization Pouch and RollSigma Medical Supplies Corp. · 2018
  • K133838Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corp. · 2015
  • K102158Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011

All 3 as Sigma Medical Supplies Corp. →All 2 as Sigma Medical Supplies Corporation →

Other applicant names beginning “Sigma”

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

Sigma Chemical Co. 231Sigma Diagnostics, Inc. 164Sigma Medical, Inc. 13Sigma 6Sigma Intl. 3Sigma Cell Culture Reagents 2Sigma Scientific Services, LLC 1Sigma Teleproducts, Inc. 1Sigma Biomedics, Inc. 1Sigma Vision, Inc. 1Sigma Intl. General Medical Apparatus, Inc. 1Sigma-Brillen 1