Cleared Traditional

K930683 - EZTEST-GAS

K930683 is an FDA 510(k) clearance for EZTEST-GAS, manufactured by Sgm Biomedical, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 1483-day FDA review.

K930683 · Sgm Biomedical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
1483d
Days
Class 2
Risk

K930683 is an FDA 510(k) clearance for the EZTEST-GAS. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Sgm Biomedical, Inc. (Bozeman, US). The FDA issued a Cleared decision on March 4, 1997 after a review of 1483 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Sgm Biomedical, Inc. devices

FDA 510(k) Submission Details - K930683

510(k) Number K930683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1993
Decision Date March 04, 1997
Days to Decision 1483 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1354d slower than avg
Panel avg: 129d · This submission: 1483d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRC Device Classification - Class 2, Special Controls

Product Code FRC Indicator, Biological Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRC Indicator, Biological Sterilization Process

All 180
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K930683.
BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)
K972747 · Propper Mfg. Co., Inc. · Jan 1998
PROSPORE II
K971430 · Raven Biological Laboratories, Inc. · May 1997
PROSPORE
K971432 · Raven Biological Laboratories, Inc. · May 1997
EZTEST
K963841 · Sgm Biotech, Inc. · Feb 1997
PROSPORE(STEARO FOR STEAM STERILIZER)
K962441 · Raven Biological Laboratories, Inc. · Sep 1996
STERITEC DISPOSABLE BIOLOGICAL TEST PACK
K961721 · Steritec Products Mfg Co, Inc. · Aug 1996