Atlas FDA

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

Aplicare, Inc. — Predicate Candidate Screening

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

42 daysmedian FDA review time
561 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K923299APLICARE ONE COMPUND BENZION TINCTURE SWABSTICKAplicare, Inc.1994-01-185610
K895039STERILE SALINE - FOR SUCTION CATHETER LUBRICATIONAplicare, Inc.1989-10-03550
K873563APLICARE STERILE WATER - FOR SUCTION CATHETER ONLYAplicare, Inc.1987-11-23820
K861557APLICARE SKIN PROTECTANT PREP PADAplicare, Inc.1986-07-11770
K861558APLICARE SKIN PROTECTANT SWABSTICKAplicare, Inc.1986-06-04400
K833185ACETONE ALCOHOL PREP PADAplicare, Inc.1983-10-31420
K833183APLICARE ONE ACETONE ALCOHOL SWABSTICKAplicare, Inc.1983-10-31420
K833184APLICARE THREE ALCOHOL SWABSTICKSAplicare, Inc.1983-10-27380
K833182APLICARE ALCOHOL PREP PADAplicare, Inc.1983-10-27380

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