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

CBO — Predicate Candidate Screening

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

14 daysmedian FDA review time

44 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K811991	SIMVAC	The Lynn Terrell Co.	1981-08-12	30
K811908	IMV MANIFOLDS	Airlife, Inc.	1981-07-16	15
K791909	IMV BUSHING #M-513	Mem Medical, Inc.	1979-10-09	14
K791912	IMV FOR MONITORING #M-510	Mem Medical, Inc.	1979-10-09	14
K791905	IMV W/BAG & TUBING #M-508	Mem Medical, Inc.	1979-10-09	14
K791911	FALL-SAFE IMV #M-511	Mem Medical, Inc.	1979-10-09	14
K791906	IMV W/BAG #M-507	Mem Medical, Inc.	1979-10-09	14
K791913	IMV MANIFOLD #M-506	Mem Medical, Inc.	1979-10-09	14
K791904	IMV W/BAG & HOSES #M-509	Mem Medical, Inc.	1979-10-09	14
K781706	RESPIRATOR/GILL 1/SIMV	Chemetron Medical Products, Inc.	1979-01-22	104
K760891	INSPIRON I.M.V. SET UP	Inspiron Corp.	1976-12-09	44
K760680	INTERMITTENT MANDATORY VENTILATION	B & F Medical Products, Inc.	1976-09-27	7
K760263	I.P.P.B. MANIFOLD/NEBULIZER (CIRCUIT)	Foregger	1976-08-04	14
K760221	I.P.P.B., DIS. W/MANIFOLD/NEBULIZER	Manner Medical Products	1976-08-03	22
K760039	VALVE, I.M.V. (U-MID ONE WAY)	Bd Becton Dickinson Vacutainer Systems Preanalytic	1976-07-16	31

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