Cleared Traditional

K210923 - Southern Implants Instrument Trays

K210923 is an FDA 510(k) clearance for Southern Implants Instrument Trays, manufactured by Southern Implants (Pty), Ltd.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K210923 · Southern Implants (Pty), Ltd. · General Hospital
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Mar 2022
Decision
338d
Days
Class 2
Risk

K210923 is an FDA 510(k) clearance for the Southern Implants Instrument Trays. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Southern Implants (Pty), Ltd. (Guateng, ZA). The FDA issued a Cleared decision on March 2, 2022 after a review of 338 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Southern Implants (Pty), Ltd. devices

FDA 510(k) Submission Details - K210923

510(k) Number K210923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2021
Decision Date March 02, 2022
Days to Decision 338 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
209d slower than avg
Panel avg: 129d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

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 172
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K210923.
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