Atlas FDA

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

Interson Corp. · Predicate Candidate Screening

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

257 daysmedian FDA review time
288 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K911116INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYSTInterson Corp.1991-12-202880
K911115INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEMInterson Corp.1991-12-172850
K911117INTERSON ENDOCAVITY PROBE FOR ATL ULTRASOUND SYSTInterson Corp.1991-12-172850
K911113INTERSON TRANSRECTAL PROBE/KONTRON ULTRASOUND SYSTInterson Corp.1991-12-172850
K911114INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEMInterson Corp.1991-11-192570
K911464INTERSON DISPOSABLE BIOPSY NEEDLEInterson Corp.1991-09-271770
K900555INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA.Interson Corp.1990-05-02850
K896680PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.Interson Corp.1990-02-14790
K895725BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBESInterson Corp.1989-11-06420

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