Cleared Traditional

K250464 - Enlight 2100 (TPL-E2103-0) (FDA 510(k) Clearance)

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

K250464 · Timpel S.A. · Anesthesiology device
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Sep 2025
Decision
204d
Days
Class 2
Risk

K250464 is an FDA 510(k) clearance for the Enlight 2100 (TPL-E2103-0). Classified as Ventilatory Electrical Impedance Tomograph (product code QEB), Class II - Special Controls.

Submitted by Timpel S.A. (São Paulo, BR). The FDA issued a Cleared decision on September 10, 2025 after a review of 204 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1505 - 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 Timpel S.A. devices

Submission Details

510(k) Number K250464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2025
Decision Date September 10, 2025
Days to Decision 204 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
65d slower than avg
Panel avg: 139d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEB Ventilatory Electrical Impedance Tomograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1505
Definition A Ventilatory Electrical Impedance Tomograph Is A Prescription Non-invasive, Non-radiological Ventilatory Device That Provides An Assessment Of Local Impedance Variation Within A Cross-section Of A Patient’s Thorax.
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

ProMedic Consulting, 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.