Atlas FDA

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

United Surgical Corp. · Predicate Candidate Screening

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

46 daysmedian FDA review time
156 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K902150PIEZO HANDPIECEUnited Surgical Corp.1990-07-05510
K870671PHACOTRON DAY PAKUnited Surgical Corp.1987-04-06460
K870806NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100United Surgical Corp.1987-03-26280
K870195UNITED SURGICAL CORP. CRYOPTIC PLUSUnited Surgical Corp.1987-02-20310
K870194UNITED SURGICAL CORP. DIATHERMIC PLUSUnited Surgical Corp.1987-02-20310
K860014SYSTEMS PLUSUnited Surgical Corp.1986-03-05610
K830741PARAMETRIC STERILITY RELEASE OF AUTOUnited Surgical Corp.1983-08-111560

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