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

Sabratek Corp. — Predicate Candidate Screening

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

200 daysmedian FDA review time

363 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K983355	SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS	Sabratek Corp.	1999-03-12	170	0
K980751	SABRATEK 4040 INFUSION PUMP	Sabratek Corp.	1999-02-24	363	0
K980619	SABRATEK PATIENT HOME MANAGEMENT SYSTEM	Sabratek Corp.	1998-08-20	183	0
K955258	3030 INFUSION PUMP	Sabratek Corp.	1996-06-03	200	0
K944293	SABRATEK SABSIL SETS	Sabratek Corp.	1995-03-23	202	0
K941984	SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP	Sabratek Corp.	1994-07-19	85	1
K914589	SABRATEK 3030 INFUSION PUMP	Sabratek Corp.	1992-05-18	215	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