Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Amsco Sterile Recoveries, Inc. · Predicate Candidate Screening

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

422 daysmedian FDA review time
472 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K932522AMSCO STERILE RECOVERIES SURGICAL PACKSAmsco Sterile Recoveries, Inc.1994-09-094720
K931143AMSCO STERILE RECOVERIES ABSORBENT TOWELSAmsco Sterile Recoveries, Inc.1994-09-085520
K931146SURGICAL DRAPES, MODIFICATIONAmsco Sterile Recoveries, Inc.1994-06-134650
K931144STERILE SURGEON'S GOWN, MODIFICATIONAmsco Sterile Recoveries, Inc.1994-06-104620
K931145NON-STERILE ISOLATION GOWNAmsco Sterile Recoveries, Inc.1994-06-104620
K931874RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USEAmsco Sterile Recoveries, Inc.1994-06-104220
K931875AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USEAmsco Sterile Recoveries, Inc.1994-06-104220
K932035NON-LINTING DELIVERY BLANKETAmsco Sterile Recoveries, Inc.1994-05-263940
K925815REUSABLE LIQUIDPROOF BOOTIEAmsco Sterile Recoveries, Inc.1993-07-092340
K921049SURGICAL DRAPEAmsco Sterile Recoveries, Inc.1992-10-012100
K920404SURGEON'S GOWNAmsco Sterile Recoveries, Inc.1992-08-182000
K920405STERILE SURGEON'S GOWNAmsco Sterile Recoveries, Inc.1992-08-182000

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