Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Dolphin Medical, Inc. — Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

108 daysmedian FDA review time

196 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K060524	DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSAB	Dolphin Medical, Inc.	2006-06-15	108
K040380	DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR,	Dolphin Medical, Inc.	2004-08-31	196
K033876	DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070	Dolphin Medical, Inc.	2004-03-11	87
K032947	NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 221	Dolphin Medical, Inc.	2003-10-17	25
K031465	MODEL 2100 PULSE OXIMETER	Dolphin Medical, Inc.	2003-10-10	155
K030629	DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER	Dolphin Medical, Inc.	2003-09-04	189
K030952	DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT,	Dolphin Medical, Inc.	2003-05-19	54
K024235	DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER	Dolphin Medical, Inc.	2003-03-17	84
K014218	OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOL	Dolphin Medical, Inc.	2002-11-07	321
K021959	DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100	Dolphin Medical, Inc.	2002-07-11	27
K012989	DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070	Dolphin Medical, Inc.	2002-03-20	195
K020075	MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMET	Dolphin Medical, Inc.	2002-02-08	30

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda