Cleared Abbreviated

K041833 - CONSOLIDATED SR AND SSE MC-SERIES STEAM...

K041833 is an FDA 510(k) clearance for CONSOLIDATED SR AND SSE MC-SERIES STEAM..., manufactured by Consolidated Machine Corp.. The device is a Class 2 General Hospital device with product code FLE cleared through the Abbreviated 510(k) pathway after a 156-day FDA review.

K041833 · Consolidated Machine Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
156d
Days
Class 2
Risk

K041833 is an FDA 510(k) clearance for the CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Consolidated Machine Corp. (Boston, US). The FDA issued a Cleared decision on December 10, 2004 after a review of 156 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 Consolidated Machine Corp. devices

FDA 510(k) Submission Details - K041833

510(k) Number K041833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2004
Decision Date December 10, 2004
Days to Decision 156 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 129d · This submission: 156d
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 76
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