Cleared Traditional

K151597 - Family of Steam Sterilizers B 28 series

K151597 is an FDA 510(k) clearance for Family of Steam Sterilizers B 28 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 266-day FDA review.

K151597 · Cefla S.C. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
266d
Days
Class 2
Risk

K151597 is an FDA 510(k) clearance for the Family of Steam Sterilizers B 28 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 March 4, 2016 after a review of 266 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 - K151597

510(k) Number K151597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2015
Decision Date March 04, 2016
Days to Decision 266 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
137d slower than avg
Panel avg: 129d · This submission: 266d
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 K151597.
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 B17 B22 Series
K161848 · Cefla S.C. · Feb 2017
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
Pre-vacuum Tabletop Autoclave
K143311 · Tuttnauer U.S.A Co, Ltd. · Jan 2015