Cleared Traditional

K201026 - sOLVe Tube (FDA 510(k) Clearance)

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

K201026 · Hytek Medical, Inc. · Anesthesiology device
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Aug 2021
Decision
477d
Days
Class 2
Risk

K201026 is an FDA 510(k) clearance for the sOLVe Tube. Classified as Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (product code CBI), Class II - Special Controls.

Submitted by Hytek Medical, Inc. (Northridge, US). The FDA issued a Cleared decision on August 10, 2021 after a review of 477 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5740 - the FDA anesthesiology and respiratory 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 Anesthesiology submissions.

View all Hytek Medical, Inc. devices

Submission Details

510(k) Number K201026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2020
Decision Date August 10, 2021
Days to Decision 477 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
338d slower than avg
Panel avg: 139d · This submission: 477d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5740
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 Anesthesiology devices follow this clearance model.

Regulatory Consultant

Acknowledge Regulatory Strategies, LLC
Allison Komiyama

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 - CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)

All 33
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