510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K041674Substantially Equivalent

The M3810a Philips Telemonitoring System with M3814a Spo2 Unit

Philips North America LLC, Andover MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041674 is the FDA 510(k) clearance record for THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT, a class II device, cleared for Philips Medical Systems on under FDA product code DQA (Oximeter). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show 2 recalls naming K041674.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Philips Medical Systems 3000 Minuteman Rd., Andover MA
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