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

BZL — Predicate Candidate Screening

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

107 daysmedian FDA review time

448 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days
K200076	Breezing Med	Tf Health Co.	2020-09-25	255
K190561	NICU V'02	Cosmed Nordic Aps	2020-09-04	549
K110810	ANASCIENT BREATH MONITOR	Invoy Technologies, LLC	2011-06-21	90
K093080	METAPHOR METABOLIC MONITOR	Treymed, Inc.	2010-01-22	114
K071533	FITMATE SERIES	Cosmed Srl	2007-09-28	115
K070858	EXPRESS SERIES	Medical Graphics Corp.	2007-04-16	19
K061731	MEDGRAPHICS ULTIMA SYSTEM	Medical Graphics Corp.	2006-09-06	78
K021490	REEVUE INDIRECT CALORIMETER, MODEL#8100	Korr Medical Technologies, Inc.	2003-01-02	238
K021605	MEDGEM	Healthetech, Inc.	2002-06-14	29
K010577	BODYGEM, MODEL HB211	Healthetech, Inc.	2002-01-10	317
K954731	OXYLOG 2	P.K. Morgan , Ltd.	1997-01-06	448
K924978	7250 METABOLIC MONITOR	Puritan Bennett Corp.	1994-09-22	721
K921565	CARDIOPULMONARY METABOLIC MEASUEMENT CART	Quiton Instrument Co.	1994-08-11	862
K931422	DELTATRAC(TM) II METABOLIC MONITOR	Datex Division Instrumentarium Corp.	1993-11-24	247
K922660	PHYSIO-DYNE EASI - LAB	Physio-Dyne	1993-04-08	309
K912906	MEDGRAPHICS PF/DX	Medical Graphics Corp.	1992-02-04	217
K895791	OXYMAX	Columbus Instruments Intl. Corp.	1990-03-28	181
K895935	ICOR CMU Q PLUS	Icor AB	1990-01-04	85
K895586	VVR/Q CALORIMETER	Vita-Stat	1989-09-22	7
K874663	MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM	Ametek/Thermox Instruments Division	1988-05-31	200
K864603	DELTATRAC(TM) METABOLIC MONITOR	Datex Division Instrumentarium Corp.	1987-03-17	113
K864852	VISTA INTERFACE SYSTEM	Vacumetrics, Inc.	1987-03-04	83
K854927	ICOR CALARIC MEASUREMENT UNIT (CMU)	Icor AB	1986-03-27	107
K853434	ERGO-PNEUMOTEST	Erich Jaeger, Inc.	1986-02-05	174
K833714	RESPIRATORY ASSESSMENT SYSTEM	Thoratec Laboratories Corp.	1983-12-29	69
K831780	METABOLIC EXERCISE TESTING SYSTEM	Warren E. Collins, Inc.	1983-09-12	102
K823695	CPM METABOLIC MONITOR	Medicor USA , Ltd.	1983-01-14	37
K822710	METABOLIC MEASUREMENT CART	Beckman Instruments, Inc.	1982-10-13	36
K821344	ENGSTROM METABOLIC COMPUTER	Lkb Instruments, Inc.	1982-05-28	23
K820905	BECKMAN MMC II METABOLIC MEAS. CART	Beckman Instruments, Inc.	1982-05-14	43
K820475	MGC/LITTON 2300	Medical Graphics Corp.	1982-03-23	32
K802417	AB O2 CONSUMPTION CALCULATOR 980	Siemens Elema AB	1980-10-23	17
K801852	MRM-2 OXYGEN CONSUMPTION MONITOR	Waters Assoc., Inc.	1980-08-20	16

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