Atlas FDA

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

Conco Medical Co. · Predicate Candidate Screening

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

20 daysmedian FDA review time
43 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K904819SHUR-LOCK ICE WRAP SYSTEMConco Medical Co.1990-12-06430
K821701RAPIDO-LASTIC IN STERILE FORMConco Medical Co.1982-07-22440
K820826STAX FINGER SPLINTConco Medical Co.1982-04-08130
K820381FINGER PROTECTORConco Medical Co.1982-03-01200
K820380CURVED FINGER SPLINTConco Medical Co.1982-03-01200
K820382FROG SPLINTConco Medical Co.1982-03-01200
K820383FINGER COTConco Medical Co.1982-02-24150
K760139BANDAGE, E-COTTON ELASTICConco Medical Co.1976-07-19200
K760142BANDAGE, RAPIDO-LASTIC COTTON/NYLONConco Medical Co.1976-07-19200
K760140BANDAGE, WRINKY-LASTIC ELASTIC GAUZEConco Medical Co.1976-07-19200
K760138BANDAGE, CEB COTTON ELASTICConco Medical Co.1976-07-19200
K760141BANDAGE, CONFO-LASTIC ALL COTTON ELASTICConco Medical Co.1976-07-19200

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