Cleared Traditional

K912471 - EAGLE 3000 SDS

K912471 is the FDA 510(k) clearance for EAGLE 3000 SDS by Amsco Co.. It is a Class 2 General Hospital device (product code FLE) cleared through the Traditional 510(k) pathway after a 388-day FDA review.

K912471 · Amsco Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
388d
Days
Class 2
Risk

K912471 is an FDA 510(k) clearance for the EAGLE 3000 SDS. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Amsco Co. (Erie, US). The FDA issued a Cleared decision on June 26, 1992 after a review of 388 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Amsco Co. devices

Submission Details

510(k) Number K912471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1991
Decision Date June 26, 1992
Days to Decision 388 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
259d slower than avg
Panel avg: 129d · This submission: 388d
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 74
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K912471.
STERRADD STERILIZATION SYSTEM
K954142 · Advanced Sterilization Products · Jun 1997
STRYKER ENCORE STERILIZER
K962755 · Stryker Corp. · Mar 1997
MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
K936181 · Midmark Corp. · Nov 1994
DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY
K920293 · Davis & Geck, Inc. · Apr 1992
MODEL #M9 ULTRACLAVE STEAM STERILIZER
K911322 · Midmark Corp. · Aug 1991
MODEL #M8 ELECTRONIC STERILIZER
K900432 · Midmark Corp. · Jul 1990