Cleared Traditional

K210992 - Altech® Exhalation Valve (Single Limb and Dual Limb) (FDA 510(k) Clearance)

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

K210992 · Meditera Tibbi Malzeme San VE Tic AS · Anesthesiology device
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Dec 2021
Decision
265d
Days
Class 2
Risk

K210992 is an FDA 510(k) clearance for the Altech® Exhalation Valve (Single Limb and Dual Limb). Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Meditera Tibbi Malzeme San VE Tic AS (Tire Izmir, TR). The FDA issued a Cleared decision on December 23, 2021 after a review of 265 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Meditera Tibbi Malzeme San VE Tic AS devices

Submission Details

510(k) Number K210992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2021
Decision Date December 23, 2021
Days to Decision 265 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
126d slower than avg
Panel avg: 139d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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

Meditera Tibbi Malzeme San VE Tic AS C/O Promedic, LLC
Paul Dryden

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.