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

Zyno Medical, LLC · Predicate Candidate Screening

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

147 daysmedian FDA review time

301 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K153193	Halo II Ambulatory Infusion System (also with trade names Ni	Zyno Medical, LLC	2016-08-30	301	4
K140783	HALO AMBULATORY INFUSION SYSTEM	Zyno Medical, LLC	2014-10-17	200	2
K132841	ZYNO MEDICAL ADMINISTRATION SET	Zyno Medical, LLC	2014-01-23	135	4
K130690	Z-800 INFUSION SYSTEM	Zyno Medical, LLC	2013-06-12	90	9
K120685	ZYNO MEDICAL ADMINISTRATION SET	Zyno Medical, LLC	2012-09-07	185	0
K100705	ZYNO Z-800 INFUSION SYSTEM MODEL Z-800	Zyno Medical, LLC	2010-07-08	118	8
K071545	Z-800 VOLUMETRIC INFUSION PUMP	Zyno Medical, LLC	2007-10-31	147	1

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