Atlas FDA

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

Aidoc Medical , Ltd. · Predicate Candidate Screening

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

90 daysmedian FDA review time
205 days90th percentile
35clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261317BriefCase-TriageAidoc Medical , Ltd.2026-05-14230
K253578BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; PerAidoc Medical , Ltd.2026-02-261010
K251195BriefCase-TriageAidoc Medical , Ltd.2026-01-272850
K252970BriefCase-Triage: CARE Multi-triage CT BodyAidoc Medical , Ltd.2026-01-071120
K253265BriefCase-TriageAidoc Medical , Ltd.2025-11-06380
K251406BriefCase-TriageAidoc Medical , Ltd.2025-05-30240
K250248BriefCase-TriageAidoc Medical , Ltd.2025-02-14180
K243548BriefCase-TriageAidoc Medical , Ltd.2024-12-11260
K242203BriefCase-QuantificationAidoc Medical , Ltd.2024-11-221190
K242837BriefCase-TriageAidoc Medical , Ltd.2024-10-18290
K241727BriefCase-TriageAidoc Medical , Ltd.2024-07-12280
K241112BriefCase-QuantificationAidoc Medical , Ltd.2024-05-15230
K231631BriefCase-QuantificationAidoc Medical , Ltd.2023-11-281760
K232083BriefCase-QuantificationAidoc Medical , Ltd.2023-11-131230
K230534BriefCase-QuantificationAidoc Medical , Ltd.2023-11-082540
K232751BriefCase-TriageAidoc Medical , Ltd.2023-10-30520
K230020BriefCaseAidoc Medical , Ltd.2023-02-01290
K222692BriefCaseAidoc Medical , Ltd.2022-12-05900
K221330BriefCaseAidoc Medical , Ltd.2022-11-181960
K220709BriefCaseAidoc Medical , Ltd.2022-10-072110
K222329BriefCaseAidoc Medical , Ltd.2022-09-28570
K222277BriefCaseAidoc Medical , Ltd.2022-08-26280
K221314BriefCaseAidoc Medical , Ltd.2022-06-03290
K221240BriefCaseAidoc Medical , Ltd.2022-05-17180
K213886BriefCaseAidoc Medical , Ltd.2022-04-261340
K213721BriefCaseAidoc Medical , Ltd.2022-03-211170
K214043BriefCaseAidoc Medical , Ltd.2022-03-14810
K202992BriefCase, RIB Fractures Triage (RibFx)Aidoc Medical , Ltd.2021-04-141960
K203508BriefCaseAidoc Medical , Ltd.2020-12-29290
K201020BriefCaseAidoc Medical , Ltd.2020-08-261310
K193298BriefCaseAidoc Medical , Ltd.2020-06-192050
K192383BriefCaseAidoc Medical , Ltd.2019-12-201120
K190896BriefCaseAidoc Medical , Ltd.2019-05-31560
K190072BriefCaseAidoc Medical , Ltd.2019-04-15900
K180647BriefCaseAidoc Medical , Ltd.2018-08-011420

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