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

Diatek, Inc. — Predicate Candidate Screening

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

60 daysmedian FDA review time

224 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K020430	DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)	Diatek, Inc.	2002-05-09	90	0
K010399	DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. C	Diatek, Inc.	2001-08-14	186	2
K895703	DIATEK MODEL 700 THERMOMETER	Diatek, Inc.	1989-12-07	76	0
K872178	MODIFICATION TO ARKIVE(TM)	Diatek, Inc.	1988-01-27	233	0
K862085	ARKIVE (TM)	Diatek, Inc.	1987-01-12	224	0
K841827	ENTEROPORT NUTRITION PUMP	Diatek, Inc.	1984-07-27	85	0
K841859	SECURA SET	Diatek, Inc.	1984-07-03	60	0
K833568	DIATEK 600 THERMOMETER SYSTEM	Diatek, Inc.	1984-01-10	90	0
K830565	SECURA SET SECONDARY ADMIN. SET	Diatek, Inc.	1983-03-09	14	0
K830377	SECURA SET PRIMARY ADMIN. SET	Diatek, Inc.	1983-03-01	25	0
K830355	SECURA IV VOLUMETRIC INFUSION PUMP	Diatek, Inc.	1983-03-01	26	0
K830448	SECURA SET VOLUME LIMITING SET	Diatek, Inc.	1983-02-25	10	0
K813468	ACC-U-THERM TEMPERATURE MONITOR	Diatek, Inc.	1982-01-07	27	0
K810575	MARTIN TRACH-SECURE	Diatek, Inc.	1981-03-17	14	0
K790416	DIATEK 500	Diatek, Inc.	1979-04-10	41	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