Cleared Abbreviated

H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (K014013) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K014013 · H & W Technology, LLC · General Hospital
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Jun 2003
Decision
567d
Days
Class 2
Risk

K014013 is an FDA 510(k) clearance for the H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM. Classified as Sterilizer, Ethylene-oxide Gas (product code FLF), Class II - Special Controls.

Submitted by H & W Technology, LLC (Rochester, US). The FDA issued a Cleared decision on June 25, 2003 after a review of 567 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all H & W Technology, LLC devices

Submission Details

510(k) Number K014013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2001
Decision Date June 25, 2003
Days to Decision 567 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
438d slower than avg
Panel avg: 129d · This submission: 567d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FLF Sterilizer, Ethylene-oxide Gas
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6860
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.