Atlas FDA

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

Amsino Intl., Inc. · Predicate Candidate Screening

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

71 daysmedian FDA review time
265 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K070873AMSURE BLADDER IRRIGATION SETAmsino Intl., Inc.2007-12-192650
K992719AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKEAmsino Intl., Inc.2000-01-121530
K974042AMSURE CLEANSING ENEMA SETAmsino Intl., Inc.1997-12-19560
K973107AMSINO I.V. ADMINISTRATION SETAmsino Intl., Inc.1997-10-02440
K973199AMSINO SUCTION CATHETERAmsino Intl., Inc.1997-09-10150
K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.1997-08-06710
K964745AMSINO URINARY DRAINAGE BAGAmsino Intl., Inc.1997-03-181120
K950780AMSINO CERVICAL SCRAPERAmsino Intl., Inc.1995-07-251540
K951528AMSINO DISPOSABLE VIGINAL SPECULUMAmsino Intl., Inc.1995-05-11380

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