Atlas FDA

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

GKF — Predicate Candidate Screening

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

49 daysmedian FDA review time
230 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total HemInstrumentation Laboratory CO2016-12-143060
K983551CRIT-SCAN II MONITORIn-Line Diagnostics Corp.1999-05-272300
K981426STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERSNova Biomedical Corp.1998-05-12260
K981425STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERSNova Biomedical Corp.1998-05-12260
K981427STAT PROFILE M ANALYZERNova Biomedical Corp.1998-05-12261
K953519MICROSPIN 24Vulcon Technologies1995-11-03990
K915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEFisher Scientific Co., LLC1992-03-11720
K915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEFisher Scientific Co., LLC1992-01-08350
K904336NEW COBE SATURATION/HEMATOCRIT MONITORCobe Laboratories, Inc.1990-12-27980
K880373IONOMETER E-HK AND ACCESSORIESSmash Ent., Inc.1988-03-17500
K870860CHEMPRO 1000(TM)Arden Medical Systems, Inc.1987-04-14420
K864646SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGEE.I. Dupont DE Nemours & Co., Inc.1987-01-05410
K864039MICROHEMATOCRIT CENTRIFUGEPlaza Medical, Inc.1986-10-29130
K802199STAT-CRIT HEMATOCRIT MEASURING INSTRUUnited States Surgical, A Division of Tyco Healthc1981-02-041470
K781059CUTTER/COMPUR MINI CENTRIFUGECutter Laboratories, Inc.1978-08-14490

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