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

Gould, Inc. — Predicate Candidate Screening

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

39 daysmedian FDA review time

107 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K911935	CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED	Gould, Inc.	1991-07-22	82	0
K861092	MODEL SP1465 CARDIAC OUTPUT COMPUTER	Gould, Inc.	1986-08-18	147	0
K860805	PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337	Gould, Inc.	1986-05-08	65	0
K855145	MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR	Gould, Inc.	1986-02-26	64	0
K854403	MODEL 2120 SPIROSCREEN	Gould, Inc.	1986-01-14	75	0
K851486	GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX	Gould, Inc.	1985-10-17	185	0
K850114	C/PES 9201, ECG STRESS TESTING SYS	Gould, Inc.	1985-02-22	39	0
K850113	C/PES 9103, ECG STRESS TESTING SYSTEM	Gould, Inc.	1985-02-08	25	0
K843555	CARDIAC COMPUTER SP1445	Gould, Inc.	1985-02-01	144	0
K843969	MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER	Gould, Inc.	1985-01-23	104	0
K843970	MODEL IM1074 END-TIDAL CO2 MODULE	Gould, Inc.	1984-10-24	13	0
K840909	AUTOMATED NON-INVASIVE PRESSURE MODULE	Gould, Inc.	1984-06-15	107	0
K840992	THERMODILUTION CATHETER	Gould, Inc.	1984-05-23	77	0
K840824	HEPARIN COATED THERMODILUTION CATHETERS	Gould, Inc.	1984-05-23	89	0
K830885	GOULD MODEL IM3000-IM3100 BATTERY POWER	Gould, Inc.	1983-06-22	93	0
K830523	CATHETER CONNECTION W/INTEGRAL INJECTATE	Gould, Inc.	1983-03-16	27	0
K823262	MODEL SP5800 #8 FRENCH INTRO. KIT	Gould, Inc.	1983-01-18	77	0
K822507	DISPOSABLE TRANSDUCER & ACCESSORIES	Gould, Inc.	1982-09-14	26	0
K821450	PRESSURE TUBING-ADULT & PEDIATRIC	Gould, Inc.	1982-05-25	11	0
K821235	HEPARIN COATED THERMODILUTION CATHETER	Gould, Inc.	1982-05-18	20	0
K811537	MODEL SP 5507 5-LUMEN THERMODILUTION CAT	Gould, Inc.	1981-06-18	17	0
K811538	MODELS TA 1017 & 1017T GRITIFLO DISPOS	Gould, Inc.	1981-06-12	11	0
K810730	MODEL SP5107 THERMODILUTION CATHETER	Gould, Inc.	1981-03-27	10	0
K810731	MODEL IM1000 INTEGRATED MONITOR	Gould, Inc.	1981-03-27	10	0
K802476	CARDIACINDEX COMPUTER MODEL SP 1435	Gould, Inc.	1980-11-19	41	0
K791844	CRITIFLO & CRITIFLO DOME	Gould, Inc.	1979-10-02	13	7
K780797	TRANSDUCER, PRESSURE, OPTION, H-P, P23ID	Gould, Inc.	1978-06-13	29	0
K780798	GOULD-STATHAM SP1405 PRESSURE MONITOR	Gould, Inc.	1978-06-13	29	0
K780425	BIOPHYSICAL MONITORING SYSTEM	Gould, Inc.	1978-04-28	42	0
K760532	COMPUTER, CARDIAC OUTPUT (#SP1425)	Gould, Inc.	1976-09-09	10	0
K760533	CATHETER, FLOW DIRECTED THERMAL DILUTION	Gould, Inc.	1976-09-09	10	0

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