Atlas FDA

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

Mps Acacia · Predicate Candidate Screening

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

64 daysmedian FDA review time
97 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K090809MPS ACACIA POWER INJECTABLE INFUSION SETMps Acacia2009-04-28340
K080328MPS ACACIA ENTERAL FEEDING TUBEMps Acacia2008-05-14970
K052451MPS ACACIA MEDFLO ELASTOMERIC PUMPMps Acacia2005-12-08920
K052946MPS ACACIA NERVE BLOCK NEEDLEMps Acacia2005-12-08490
K032934MPS ACACIA SAFEGUARD HUBER DEVICEMps Acacia2003-11-13520
K011117MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSIMps Acacia2001-07-09880
K003476MPS ACACIA PAIN KITMps Acacia2001-01-12640

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