Cleared Traditional

K203177 - Sterisystem Dry-Base Instrument Tray

K203177 is the FDA 510(k) clearance for Sterisystem Dry-Base Instrument Tray by O&M Halyard, Inc.. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 433-day FDA review.

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
304d slower than avg
Panel avg: 129d · 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.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 164
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K203177.
Neodent Implant System-Helix NGM Compact Surgical Kit Cases
K214051 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Apr 2022
Surgical Trays
K212281 · Dentsply Sirona, Inc. · Mar 2022
Southern Implants Instrument Trays
K210923 · Southern Implants (Pty), Ltd. · Mar 2022
EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device
K213209 · K1 Medical, LLC · Dec 2021
TCAT TKA Instrument Tray
K203468 · THINK Surgical, Inc. · Dec 2021
Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray
K212932 · Nobel Biocare Services AG · Dec 2021