Cleared Traditional

S.I.N. Instrument Kits (K201688) - FDA 510(k) Clearance

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

K201688 · S.I.N. ? Sistema DE Implante Nacional S.A. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2020
Decision
121d
Days
Class 2
Risk

K201688 is an FDA 510(k) clearance for the S.I.N. Instrument Kits. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by S.I.N. ? Sistema DE Implante Nacional S.A. (São Paulo, BR). The FDA issued a Cleared decision on October 21, 2020 after a review of 121 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 S.I.N. ? Sistema DE Implante Nacional S.A. devices

Submission Details

510(k) Number K201688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2020
Decision Date October 21, 2020
Days to Decision 121 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
8d faster than avg
Panel avg: 129d · This submission: 121d
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 Consultant

PaxMed International, LLC
Kevin A. Thomas

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

All 139
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K201688.
NUVO Implant System – NUVO Instrument Kit Cases
K202515 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Nov 2020
Sweden & Martina Surgical Tray (Model ZSHORTY-INT)
K182084 · Sweden & Martina S.P.A. · Nov 2020
OsteoMed ExtremiFix Mini & Small System Tray
K202105 · Osteomed, LLC · Oct 2020
Steripack cases and Tray Systems
K193066 · Avalign Technologies, Inc. · Aug 2020
Mini Sterilizable Tray
K200858 · Implant Direct Sybron Manufacturing, LLC · Aug 2020
Benesta Medical Sterilization Tray
K193603 · Caldera Medical, Inc. · Jul 2020