Atlas FDA

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

Careside, Inc. — Predicate Candidate Screening

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

67 daysmedian FDA review time
117 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K020484CARESIDE LDHCareside, Inc.2002-07-031400
K020486CARESIDE GGTCareside, Inc.2002-07-011380
K020487CARESIDE ALTCareside, Inc.2002-06-041110
K020488CARESIDE TRGLYCERIDECareside, Inc.2002-04-15610
K002792CARESIDE CHOLINESTERASECareside, Inc.2000-11-08620
K001462CARESIDE HEMOGLOBINCareside, Inc.2000-08-211030
K993771CARESIDE DIRECT BILIRUBINCareside, Inc.1999-12-27490
K993634CARESIDE ANALYZERCareside, Inc.1999-12-02360
K992475CARESIDE CO2, TOTALCareside, Inc.1999-09-15510
K991717CARESIDE MGCareside, Inc.1999-08-10820
K991371CARESIDE AMMONIACareside, Inc.1999-08-031050
K991065CARESIDE PTCareside, Inc.1999-07-261170
K990439CARESIDE CKCareside, Inc.1999-04-19670
K990434CARESIDE CKMBCareside, Inc.1999-04-19670
K990036CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000Careside, Inc.1999-03-18710
K990009CARESIDE ASTCareside, Inc.1999-03-16710
K990025CARESIDE AMYLASECareside, Inc.1999-02-08350
K990024CARESIDE ALKALINE PHOSPHATASECareside, Inc.1999-01-1380
K983789CARESIDE CALCIUM, ORIGINALCareside, Inc.1998-12-17510
K981604CARESIDE URIC ACIDCareside, Inc.1998-06-25580
K981610CARESIDE ANALYZERCareside, Inc.1998-06-25560
K981588CARESIDE TOTAL BILIRUBINCareside, Inc.1998-06-23500

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