Cleared Traditional

K161848 - Family of Steam sterilizers B17 B22 Series (FDA 510(k) Clearance)

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

K161848 · Cefla S.C. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2017
Decision
233d
Days
Class 2
Risk

K161848 is an FDA 510(k) clearance for the Family of Steam sterilizers B17 B22 Series. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on February 23, 2017 after a review of 233 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 Cefla S.C. devices

Submission Details

510(k) Number K161848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2016
Decision Date February 23, 2017
Days to Decision 233 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 128d · This submission: 233d
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 183
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K161848.
Enbio PRO
K260254 · Enbio Group AG · Feb 2026
Getinge GSS67N Series Steam Sterilizer
K252307 · Maquet GmbH (A Getinge Group Company) · Jan 2026
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
K250168 · Lucas Lifecare · Dec 2025
Cassette Autoclave (ACA5)
K250164 · Guangzhou Ajax Medical Equipment Co., Ltd. · Aug 2025
Steam Sterilizer (2545D)
K243994 · Ningbo Ican Machines Co., Ltd. · Jun 2025
FRONT-LINE Field Sterilizer (FL135)
K243801 · Fort Defiance Industries, LLC · Mar 2025