Atlas FDA

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

Koi, Inc. — Predicate Candidate Screening

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

25 daysmedian FDA review time
618 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K843247KOI PACHYMETERKoi, Inc.1986-04-306180
K830366DIAMOND KNIFEKoi, Inc.1983-03-09330
K812764KOI BLUE FIELD ENTOPTOSCOPEKoi, Inc.1981-12-02610
K812450KOI DIAMOND KNIFEKoi, Inc.1981-09-21240
K812097KOI LACREMAL HOOK & DILATORKoi, Inc.1981-08-18250
K812010KOI LACRIMAL INTUBATION SYSTEMKoi, Inc.1981-07-28110
K812011BLADE GAUGEKoi, Inc.1981-07-28110

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