Cleared Abbreviated

K991575 - PRIMUS STEAM STERILIZERS

K991575 is an FDA 510(k) clearance for PRIMUS STEAM STERILIZERS, manufactured by Primus Sterilizer Co., Inc.. The device is a Class 2 General Hospital device with product code FLE cleared through the Abbreviated 510(k) pathway after a 211-day FDA review.

K991575 · Primus Sterilizer Co., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
211d
Days
Class 2
Risk

K991575 is an FDA 510(k) clearance for the PRIMUS STEAM STERILIZERS. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Primus Sterilizer Co., Inc. (Omaha, US). The FDA issued a Cleared decision on December 3, 1999 after a review of 211 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Primus Sterilizer Co., Inc. devices

FDA 510(k) Submission Details - K991575

510(k) Number K991575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1999
Decision Date December 03, 1999
Days to Decision 211 days
Submission Type Abbreviated
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
82d slower than avg
Panel avg: 129d · This submission: 211d
Pathway characteristics
Standards-based clearance path.

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 105
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K991575.
STERIS AMSCO MILLENNIUM STEAM STERILIZER
K000077 · STERIS Corporation · Mar 2000
CASTLE SERIES 100HC STEAM STERILIZERS
K994314 · Getinge/Castle, Inc. · Feb 2000
MIDMARK M4*9 EASYCLAVE STEAM STERILIZER
K992744 · Midmark Corp. · Jan 2000
MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
K990189 · Midmark Corp. · Apr 1999
STERIS TEN SIXTEEN STEAM STERILIZER
K982332 · STERIS Corporation · Jan 1999
STATIM 5000 CASSETTE AUTOCLAVE
K983679 · Scican · Jan 1999