Atlas FDA

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

Salt Creek Medical Technologies — Predicate Candidate Screening

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

16 daysmedian FDA review time
136 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K864683NEONATAL FEEDING KITSalt Creek Medical Technologies1987-04-171360
K871042URINE METER, 250CCSalt Creek Medical Technologies1987-03-2580
K871087S.C.M.T. PERFORATORSalt Creek Medical Technologies1987-03-2350
K871075SCMT UMBILICAL CLAMPSalt Creek Medical Technologies1987-03-2350
K864296S.C.T. MULTI PORT, INJECTION SITESalt Creek Medical Technologies1987-03-021220
K864682SALT CREEK P.I. TRAYSalt Creek Medical Technologies1987-01-06350
K864692EXTENSION SETSSalt Creek Medical Technologies1986-12-18160
K864693I.V. START KITSSalt Creek Medical Technologies1986-12-16140

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