Cleared Abbreviated

K213545 - Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 (FDA 510(k) Clearance)

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

K213545 · Steelco S.P.A. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2023
Decision
451d
Days
Class 2
Risk

K213545 is an FDA 510(k) clearance for the Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Steelco S.P.A. (Riese Pio X, IT). The FDA issued a Cleared decision on February 2, 2023 after a review of 451 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 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 Steelco S.P.A. devices

Submission Details

510(k) Number K213545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2021
Decision Date February 02, 2023
Days to Decision 451 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
323d slower than avg
Panel avg: 128d · This submission: 451d
Pathway characteristics
Standards-based clearance path.

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 Consultant

H & W Technology, LLC
Jonathan A Wilder

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLE Sterilizer, Steam

All 183
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K213545.
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