510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K193350Substantially Equivalent

Leadtek Fingertip Pulse Oximeter

Leadtek Research, Inc., New Taipei City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193350 is the FDA 510(k) clearance record for Leadtek Fingertip Pulse Oximeter, a class II device, cleared for Leadtek Research, Inc. on under FDA product code DQA (Oximeter). FDA records list 2 510(k) clearances for Leadtek Research, Inc., from to . As of , FDA records show no recalls naming K193350.

Clearance record

Decision date
Received
(146 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Leadtek Research, Inc. 18f, #166, Jian-Yi Rd., Zhonghe Dist, New Taipei City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQA

Trailing 12 months
13 clearances under product code DQA in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQA, trailing twelve months
MonthClearances
November 20252
December 20253
January 20261
February 20262
March 20260
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20261