510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250464Substantially Equivalent

Enlight 2100 (TPL-E2103-0)

Timpel S.A., São Paulo, BR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250464 is the FDA 510(k) clearance record for Enlight 2100 (TPL-E2103-0), a class II device, cleared for Timpel S.A. on under FDA product code QEB (Ventilatory Electrical Impedance Tomograph). FDA's definition for product code QEB reads: "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". FDA records list 4 510(k) clearances for Timpel S.A., from to . As of , FDA records show no recalls naming K250464.

Clearance record

Decision date
Received
(204 days to decision)
Product code
QEB Ventilatory Electrical Impedance Tomograph
Regulation
21 CFR 868.1505
Device class
Class II
Review panel
Anesthesiology
Applicant
Timpel S.A. Rua Simão Álvares, 356 Cj 41/42, São Paulo, BR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEB

Trailing 12 months

FDA records hold no clearances under product code QEB in the trailing twelve months.

FDA records show no clearances under product code QEB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QEB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260