Cleared Traditional

K203177 - Sterisystem Dry-Base Instrument Tray (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203177 · O&M Halyard, Inc. · General Hospital

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Jan 2022

Decision

433d

Days

Class 2

Risk

K203177 is an FDA 510(k) clearance for the Sterisystem Dry-Base Instrument Tray. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by O&M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on January 2, 2022 after a review of 433 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. 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 O&M Halyard, Inc. devices

Submission Details

510(k) Number	K203177 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 26, 2020
Decision Date	January 02, 2022
Days to Decision	433 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

305d slower than avg

Panel avg: 128d · This submission: 433d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 880.6850

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.