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

Diasol, Inc. — Predicate Candidate Screening

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

59 daysmedian FDA review time
348 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K130511CITRISOL ACID CONCENTRATEDiasol, Inc.2014-02-103480
K020231DIASOL-ADDITIVESDiasol, Inc.2002-10-212710
K020230DIASOL-BICARBDiasol, Inc.2002-04-23900
K011004NEEDLELOK HYPODERMIC NEEDLE PROTECTIONDiasol, Inc.2001-05-24500
K010958FISTULOK FISTULA NEEDLE PROTECTIONDiasol, Inc.2001-05-18490
K011003SAFESTING AND SAFESTING HUBDiasol, Inc.2001-04-20160
K993187SHELLY PROTECTED AV FISTULA NEEDLEDiasol, Inc.1999-11-05430
K992999DAISY PROTECTED SCALP VEIN SETDiasol, Inc.1999-11-05590
K992653SHELLY PROTECTED AV FISTULA NEEDLEDiasol, Inc.1999-10-27820
K993212DRYASOL ACID CONCENTRATE MIXDiasol, Inc.1999-10-22280

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