510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K012626Substantially Equivalent

Osi Medical Dolphin Stand-Alone Pulse Oximeter & Digital Dolphin Disposable Optical Sendor

Osi Medical, Inc., Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012626 is the FDA 510(k) clearance record for OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR, a class II device, cleared for Osi Medical, Inc. on under FDA product code DQA (Oximeter). FDA records list 3 510(k) clearances for Osi Medical, Inc., from to . As of , FDA records show no recalls naming K012626.

Clearance record

Decision date
Received
(81 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Osi Medical, Inc. 13801 Mccormick Dr., Tampa FL
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