Cleared Abbreviated

Bravo G4 Chamber Autoclave (K210326) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K210326 · Scican , Ltd. · General Hospital
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Jul 2021
Decision
147d
Days
Class 2
Risk

K210326 is an FDA 510(k) clearance for the Bravo G4 Chamber Autoclave. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Scican , Ltd. (Toronto, CA). The FDA issued a Cleared decision on July 1, 2021 after a review of 147 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Scican , Ltd. devices

Submission Details

510(k) Number K210326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2021
Decision Date July 01, 2021
Days to Decision 147 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 129d · This submission: 147d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
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 - FLE Sterilizer, Steam

All 61
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K210326.
Enbio S
K210279 · Enbio Group AG · Oct 2021
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AMSCO 600 Medium Steam Sterilizer
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Getinge GSS610N Series Steam Sterilizer
K201927 · Maquet GmbH · Mar 2021
Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS)
K203061 · STERIS Corporation · Nov 2020
STATClave G4 Chamber Autoclave
K192910 · Scican , Ltd. · Jun 2020