Cleared Traditional

K912471 - EAGLE 3000 SDS

K912471 is an FDA 510(k) clearance for EAGLE 3000 SDS, manufactured by Amsco Co.. The device is a Class 2 General Hospital device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K912471

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
Combination Product No
PCCP Authorized No
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.

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 185
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K912471.
TUTTNAUER LSI (AUTOMATIC)
K920478 · Tuttnauer Co. , Ltd. · Jul 1993
STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510
K921613 · Dept. of the Army · Jan 1993
STATIM CASSETT AUTOCLAVE, MODIFICATION
K915054 · Scican · Aug 1992
DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY
K920293 · Davis & Geck, Inc. · Apr 1992
MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER
K910777 · Mdt Biologic Co. · Mar 1992
MAXIMA-10
K911206 · Stirn Industries · Nov 1991
K912471 · EAGLE 3000 SDS
Download PDF FDA Summary Amsco Co.