Cleared Traditional

Enbio S (K210279) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210279 · Enbio Group AG · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
270d
Days
Class 2
Risk

K210279 is an FDA 510(k) clearance for the Enbio S. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Enbio Group AG (Oensingen, CH). The FDA issued a Cleared decision on October 29, 2021 after a review of 270 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Enbio Group AG devices

Submission Details

510(k) Number K210279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2021
Decision Date October 29, 2021
Days to Decision 270 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
141d slower than avg
Panel avg: 129d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K210279.
Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135
K213457 · Fort Defiance Industries, LLC · Mar 2022
Enbio S
K213991 · Enbio Group AG · Feb 2022
T-Edge 10, T-Edge 11
K213080 · Tuttnauer , Ltd. · Jan 2022
AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers
K212424 · STERIS Corporation · Oct 2021
AMSCO 600 Medium Steam Sterilizer
K211500 · STERIS Corporation · Aug 2021
Bravo G4 Chamber Autoclave
K210326 · Scican , Ltd. · Jul 2021