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

Cardiopulmonary Corp. — Predicate Candidate Screening

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

69 daysmedian FDA review time

459 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K130208	BERNOULLI ENTERPRISE SOFTWARE	Cardiopulmonary Corp.	2013-12-20	326
K091461	BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE	Cardiopulmonary Corp.	2009-08-14	88
K061932	BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE	Cardiopulmonary Corp.	2006-09-14	69
K051283	MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTW	Cardiopulmonary Corp.	2005-06-23	37
K020018	MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTW	Cardiopulmonary Corp.	2002-02-21	49
K011861	BERNOULLI VENTILATOR MANAGEMENT SYSTEM	Cardiopulmonary Corp.	2001-11-06	145
K990429	MODIFICATION OF VENTURI VENTILATOR	Cardiopulmonary Corp.	1999-02-24	13
K982174	VENTURI VENTILATOR	Cardiopulmonary Corp.	1998-06-24	7
K943412	VENTURI VENTILATOR	Cardiopulmonary Corp.	1995-10-16	459

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