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

Neomed, Inc. — Predicate Candidate Screening

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

78 daysmedian FDA review time

169 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K183540	Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL),	Neomed, Inc.	2019-04-30	131	0
K161039	NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL	Neomed, Inc.	2016-06-17	65	0
K152857	NeoMed NeoConnect Enteral Syringes with ENFit Connector and	Neomed, Inc.	2015-12-17	78	0
K143344	NeoMed NeoConnect Enteral Syringes with ENFit Connector	Neomed, Inc.	2015-04-09	139	0
K122373	NEOMED ORAL/ENTERAL SYRINGE	Neomed, Inc.	2012-09-20	45	0
K120182	NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES	Neomed, Inc.	2012-04-19	90	0
K100288	NEOMED ENTERAL ONLY EXTENSION SET	Neomed, Inc.	2010-08-03	183	0
K092908	NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD	Neomed, Inc.	2010-03-10	169	0
K082238	NEOMED POLYURETHANE FEEDING TUBE	Neomed, Inc.	2008-10-01	55	1
K081515	NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC	Neomed, Inc.	2008-07-21	52	0
K073596	NEOMED SINGLE LUMEN UMBILICAL CATHETER	Neomed, Inc.	2008-02-22	63	0
K072881	NEOMED Enteral FEEDING TUBE	Neomed, Inc.	2008-01-09	92	0
K072997	NEOMED URINARY CATHETER	Neomed, Inc.	2007-12-19	56	0

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