Atlas FDA

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

Mac Lee Medical Products · Predicate Candidate Screening

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

21 daysmedian FDA review time
161 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K872953DISPOSABLE I.V. ADMINISTRATION SETMac Lee Medical Products1988-01-061610
K872006DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFFMac Lee Medical Products1987-11-171750
K870995SCALP VEIN SETMac Lee Medical Products1987-07-311420
K864777MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CCMac Lee Medical Products1986-12-29210
K864781MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CCMac Lee Medical Products1986-12-29210
K864779MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CCMac Lee Medical Products1986-12-29210
K864778MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CCMac Lee Medical Products1986-12-29210
K864782MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CCMac Lee Medical Products1986-12-23150
K864780MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CCMac Lee Medical Products1986-12-23150
K864783MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CCMac Lee Medical Products1986-12-23150
K841710MAC LEE VAGINAL IRRIGATORMac Lee Medical Products1984-06-19560
K841711MAC LEE SITZ BATHMac Lee Medical Products1984-05-07130
K830192MAC LEE UI URINE COLLECTION BAGMac Lee Medical Products1983-02-01120
K791863MAC LEE ENEMADMac Lee Medical Products1979-10-0280

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