Cleared Traditional

K792558 - CONTAINER SYSTEM

K792558 is an FDA 510(k) clearance for CONTAINER SYSTEM, manufactured by Aesculap Instruments Corp.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K792558 · Aesculap Instruments Corp. · General Hospital
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Dec 1979
Decision
15d
Days
Class 2
Risk

K792558 is an FDA 510(k) clearance for the CONTAINER SYSTEM. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Aesculap Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1979 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aesculap Instruments Corp. devices

FDA 510(k) Submission Details - K792558

510(k) Number K792558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1979
Decision Date December 27, 1979
Days to Decision 15 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 129d · This submission: 15d
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 Peers - FLE Sterilizer, Steam

All 135
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K792558.
MODIFIED CASTLE POWERCLAVE
K870975 · Castle Co. · Apr 1987
RITTER STERILIZER
K801309 · Sybron Corp. · Jun 1980
STERILIZING CASE CAT. NO. 65199
K800080 · Edward Weck, Inc. · Jan 1980
STERILIZER, EAGLE 2000
K781684 · American Sterilizer Co. · Oct 1978
STERILIZERS, 3100 SERIES TRIM LINE
K771229 · Castle Co. · Aug 1977
STERILIZER, SERIES 3000, MODIFICATION TO
K770682 · Castle Co. · May 1977