510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011365Substantially Equivalent

Vitalsat Pulse Oximeter, Model Ic32000

Island Critical Care Corp., Stratford, P.E.I., CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011365 is the FDA 510(k) clearance record for VITALSAT PULSE OXIMETER, MODEL IC32000, a class II device, cleared for Island Critical Care Corp. on under FDA product code DQA (Oximeter). FDA records list one 510(k) clearance for Island Critical Care Corp. As of , FDA records show no recalls naming K011365.

Clearance record

Decision date
Received
(175 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Island Critical Care Corp. 9 Myrtle St., Stratford, P.E.I., CA
510(k) summary
Summary
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