510(k) Report

FDA applicant

Sgm Biotech, Inc.

Bozeman, MT4 decisions1994–20106 recalls

FDA records 4 decisions for Sgm Biotech, Inc. (Bozeman, MT) from 1994 to 2010: 4 510(k) clearances. All are in product code FRC (Indicator, Biological Sterilization Process). Its devices cite 6 predicates, 3 of them its own earlier devices. 6 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 Sgm Biotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

6in 2013

2013: 6
2007high 6 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sgm Biotech, Inc.’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?

  • FRCIndicator, Biological Sterilization Process4decisions

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 8 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.

  • K963841EztestSgm Biotech, Inc. · 19975cite it
  • K930682Eztest-SteamSgm Biotech, Inc. · 19942cite it
  • K093794Smart-Read Eztest-Steam Scbi and Test PackSgm Biotech, Inc. · 20101cites it

What has FDA decided for it lately?

  • K093794Smart-Read Eztest-Steam Scbi and Test PackSgm Biotech, Inc. · 20102 recalls
  • K091950Smart-Well Eztest IncubatorSgm Biotech, Inc. · 2010
  • K963841EztestSgm Biotech, Inc. · 19971 recall
  • K930682Eztest-SteamSgm Biotech, Inc. · 19944 recalls

All 4 as Sgm Biotech, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K093794Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and…Aug 2, 2013Class II
  • K930682EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam…Jun 10, 2013Class II
  • K930682Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product…Jun 10, 2013Class II
  • K930682Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product…Jun 10, 2013Class II
  • K930682Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the…Jun 4, 2013Class II
  • K093794Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in…Jun 4, 2013Class II