Cleared Traditional

K161848 - Family of Steam sterilizers B17 B22 Series

K161848 is an FDA 510(k) clearance for Family of Steam sterilizers B17 B22 Series, manufactured by Cefla S.C.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K161848 · Cefla S.C. · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K161848

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 129d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLE Device Classification - Class 2, Special Controls

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 Consultant

Isemed S.R.L.
Maurizio Pantaleoni

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLE Sterilizer, Steam

All 123
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K161848.
Getinge GSS67N Series Steam Sterilizer
K172159 · Maquet GmbH · Jan 2018
Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer
K163337 · Midmark Corporation · Aug 2017
Belimed Steam Sterilizer MST-H TOP 5000
K170228 · Belimed AG · May 2017
Family of Steam Sterilizers B 28 series
K151597 · Cefla S.C. · Mar 2016
BELIMED STEAM STERILIZER MST-H
K141879 · Sauter AG · Jun 2015
STERISAFE HP TABLE-TOP STEAM STERILIZER
K140736 · Milton E Pedrazzi D.D.S., Inc. · Jan 2015