Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Ark Diagnostics, Inc. — Predicate Candidate Screening

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

166 daysmedian FDA review time
294 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232522ARK Levetiracetam II AssayArk Diagnostics, Inc.2024-02-271930
K232017ARK Methotrexate II AssayArk Diagnostics, Inc.2023-12-201660
K231752ARK Hydrocodone AssayArk Diagnostics, Inc.2023-11-091470
K201089ARK Lacosamide AssayArk Diagnostics, Inc.2021-08-054690
K200197ARK Fentanyl II AssayArk Diagnostics, Inc.2020-02-26300
K182280ARK Tramadol AssayArk Diagnostics, Inc.2018-12-101100
K182779ARK EDDP AssayArk Diagnostics, Inc.2018-11-21510
K180427ARK Fentanyl AssayArk Diagnostics, Inc.2018-06-061100
K163359ARK Methotrexate AssayArk Diagnostics, Inc.2017-08-182610
DEN160033ARK Voriconazole II Assay Test SystemArk Diagnostics, Inc.2017-05-052940
K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine MetaboArk Diagnostics, Inc.2016-08-092370
K111904ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METArk Diagnostics, Inc.2011-10-181050
K101574ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABArk Diagnostics, Inc.2010-11-231690
K101305ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROLArk Diagnostics, Inc.2010-10-291720
K091884ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONArk Diagnostics, Inc.2009-12-091680
K091653ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARArk Diagnostics, Inc.2009-11-021460
K083799TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMAArk Diagnostics, Inc.2009-04-161150

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