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

Sun Biomedical Laboratories, Inc. — Predicate Candidate Screening

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

95 daysmedian FDA review time
208 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023856VISUALINE METHADONE DIPSTRIPTESTSun Biomedical Laboratories, Inc.2003-08-252790
K023648VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETSun Biomedical Laboratories, Inc.2003-05-061880
K014089VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATESSun Biomedical Laboratories, Inc.2002-04-251350
K020136VISUALINE BARBITURATES DIPSTRIP TESTSun Biomedical Laboratories, Inc.2002-03-20640
K011499VISUALINE AMPHETAMINE DIPSTRIP ASSAYSun Biomedical Laboratories, Inc.2001-07-17630
K010177VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAYSun Biomedical Laboratories, Inc.2001-05-171190
K993485VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DESun Biomedical Laboratories, Inc.1999-12-27740
K983790VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINESun Biomedical Laboratories, Inc.1999-03-011250
K981314VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONESun Biomedical Laboratories, Inc.1998-09-041470
K972032VISUALINE II METHAMPHETIMINESun Biomedical Laboratories, Inc.1997-08-12710
K963606VISUALINE COMBO V (COCAINE/THC) TESTSun Biomedical Laboratories, Inc.1996-10-30510
K963408VISUALINE D HCGSun Biomedical Laboratories, Inc.1996-10-18500
K953105VISUALINE II BENZODIAZEPINESSun Biomedical Laboratories, Inc.1995-10-05940
K950445VISUALINE II CANNABINOIDS (THC)Sun Biomedical Laboratories, Inc.1995-05-02950
K950369VISUALINE II COCAINESun Biomedical Laboratories, Inc.1995-03-21490
K943248VISUALINE II MORPHINE/OPIATES/HEROINSun Biomedical Laboratories, Inc.1995-01-302080
K943239VISUALINE II HCGSun Biomedical Laboratories, Inc.1994-12-071540

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