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

Namic — Predicate Candidate Screening

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

39 daysmedian FDA review time

484 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K953676	BREEZE DIGITAL INFLATION DEVICE	Namic	1996-03-29	235	0
K951722	PERCEPTOR COMPENSATOR MORSE MANIFOLD	Namic	1996-03-25	346	0
K921322	MORSE ANESTHESIA MANIFOLD	Namic	1993-07-09	484	0
K822100	HIGH PRESSURE CONTRAST INJECTION LINE	Namic	1982-08-24	39	0
K813549	CONTINUOUS FLUSH DEVICE	Namic	1982-01-12	22	0
K790082	ARTERIAL EXTENSION SET	Namic	1979-01-25	13	0
K790083	CATHETER, ARTERIAL LINE	Namic	1979-01-25	13	0
K782095	STOPCOCKS, MANIFOLDS	Namic	1979-01-23	36	5

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