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

CCN — Predicate Candidate Screening

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

75 daysmedian FDA review time

211 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K934945	FLOWMETER NIPPLE ADAPTOR	Cardio-Search , Ltd.	1993-11-17	35
K920783	OXYGEN FLOW CONTROLLER	Puritan Bennett Corp.	1992-09-18	211
K872038	NEB-U-VENT	Design Technologies, Inc.	1987-08-10	75
K871262	MODIFIED NOFLO I	Design Technologies, Inc.	1987-07-21	112
K863613	NO-FLO I	Design Technologies, Inc.	1986-12-15	90
K863657	OXYGEN CONSERVATOR	Salter Labs	1986-10-15	27
K863659	FLOW INTERRUPTION INDICATOR	Salter Labs	1986-10-15	27
K823775	BORDON GAGE REGULATOR #BG	Timeter Instrument Corp.	1983-01-14	31
K802037	VITAMIN B12 FOLATE RADIOASSAY	Corning Medical & Scientific	1980-11-21	91

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