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

Acacia, Inc. — Predicate Candidate Screening

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

100 daysmedian FDA review time

304 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K142527	Extension Set with BD Q-Syte Luer Access Split Septum	Acacia, Inc.	2014-09-19	11	0
K122449	ENTERAL NUTRITION WARMER	Acacia, Inc.	2013-06-13	304	0
K111381	MEDI-SIS SYRINGE INFUSION SYSTEM	Acacia, Inc.	2012-01-13	241	0
K103165	BLOOD SAMPLING SET	Acacia, Inc.	2010-11-10	14	0
K092986	ACACIA PISTON SYRINGE	Acacia, Inc.	2009-10-27	29	1
K972538	FLOW-EZE BLUNT CANNULA (1999BC)	Acacia, Inc.	1998-07-15	372	0
K931095	SPRING LOADED SYRINGE	Acacia, Inc.	1993-09-16	197	0
K912771	ACACIAS PHARM/PUMP	Acacia, Inc.	1992-02-14	235	0
K901063	LUER LOCK TRANSFER PIN	Acacia, Inc.	1990-07-06	121	0
K896990	PHARMULATOR	Acacia, Inc.	1990-03-23	100	0
K894206	INTOPO	Acacia, Inc.	1989-10-27	130	0
K894217	SYRINGE TIP ADAPTOR	Acacia, Inc.	1989-09-12	85	0
K853212	FLOW EASE(PLASTIC VENTED NEEDLE)	Acacia, Inc.	1985-09-19	50	0
K850757	TANDEM SETS I.V.	Acacia, Inc.	1985-04-04	38	0
K850962	OPHTHALMIC DROPPER BOTTLES	Acacia, Inc.	1985-03-21	13	0
K802561	HI VOLUME PUMPING CHAMBER	Acacia, Inc.	1980-10-31	15	0
K782113	CAP, TAMPER PROOF PLASTIC	Acacia, Inc.	1979-06-01	164	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