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

BZM — Predicate Candidate Screening

26 FDA 510(k) clearances under this product code; the 50 most recent screened below.

147 daysmedian FDA review time

270 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days
K102229	PULMOTRACK 2020 SYSTEM	Karmelsonix	2011-03-04	207
K090863	PERSONAL WHEEZOMETER	Karmelsonix	2009-09-21	175
K071955	WIM-PC, MODEL 1010	Karmelsonix	2007-11-01	108
K012387	STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM	Stethographics, Inc.	2002-04-23	270
K980878	PULMOTRACK,MODEL 1010	Karmel Medical Acoustic Technologies , Ltd.	1998-12-28	294
K974200	ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM	Orca Diagnostics Corp.	1998-07-21	253
K955432	CPX, CCM, CATH WITH 15% CO2	Medical Graphics Corp.	1996-07-01	216
K923209	MEDGRAPHICS EXERCISE CONSULT	Medical Graphics Corp.	1993-03-11	253
K911143	PB100 DIAGNOSTIC SPIROMETER	Puritan Bennett Corp.	1991-11-29	260
K896345	EXERCISE EVALUATION SYSTEM 2010	Medical Graphics Corp.	1990-01-20	78
K880550	BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS	Medimicro Systems, Inc.	1988-07-25	167
K874902	SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY	Gomi Medical Instruments	1988-06-07	189
K871711	MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM	Medical Graphics Corp.	1987-09-25	147
K864911	EXERSYSTEM(TM) MMC 5000	Med Science	1987-08-21	249
K864885	SPIROVISION	Futuremed Div. of Future Impex Corp.	1987-01-15	34
K863953	SPIROMETRICS MODEL 2500 FLOWMATE(TM)	Spirometrics, Inc.	1987-01-15	97
K861929	PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070	Medical Graphics Corp.	1986-09-26	129
K853190	SUPERSPIRO	Cdx Corp.	1985-09-26	58
K851706	UNIVERSAL COMPUTER INTERFACE SYSTEM	Vacumetrics, Inc.	1985-05-03	8
K842782	PHYSIOLOGICAL ANALYZER CM-710	Cybermedic, Inc.	1984-08-17	31
K831586	CM-VII PHYSIOLOGIC ANALYZER	Cybermedic, Inc.	1984-03-19	307
K820035	CDX 200	Cdx Corp.	1982-03-10	62
K801496	PULMONARY LAB AUTOMATION SYSTEM	Medical Graphics Corp.	1980-07-21	25
K801495	CARDIO-PULMONARY EXERCISE STRESS SYSTEM	Medical Graphics Corp.	1980-07-21	25
K791229	CYBER DX 100	Cyber Diagnostics	1979-07-30	21
K771371	SCREENING COMPUTEO SC-20	Cavitron Corp.	1977-08-04	10

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