Atlas FDA

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

FHS — Predicate Candidate Screening

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

58 daysmedian FDA review time
106 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K812811MICROCOIL 80 DIALYZERErika, Inc.1981-12-03580
K811974MICROCOIL 150 DIALYZERErika, Inc.1981-09-16650
K801634THE VITA 2 DISPOSABLE DIALYZERBellco Artifidial Organ Spec., Inc.1980-12-171550
K800723MICRO-COIL 100 COIL DIALYZERErika, Inc.1980-05-14430
K800174GAMBRO LUNDIA COIL DIALYZERGambro, Inc.1980-02-13190
K790223DIALYZER, CD-800 COILTravenol Laboratories, S.A.1979-03-26520
K781102DIALYZER, DISP., COIL, LUNDIAGambro, Inc.1978-10-171060
K771349MODIFICATION TO KIDNEY DIALYZERErika, Inc.1977-08-02120
K770735DIALYZER, COIL, CD, LSA, 5M1765Travenol Laboratories, S.A.1977-05-10190
K761358COIL DIALYZER MODEL ALT 140Bentley Laboratories, Inc.1977-01-10120
K760702ERI-FLO 900 DIALYZERErika, Inc.1976-11-19580
K760374DIALYZER (MODEL 1850)Erika, Inc.1976-10-27830

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