Atlas FDA

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

Varian Canada, Inc. — Predicate Candidate Screening

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

63 daysmedian FDA review time
167 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIVarian Canada, Inc.1995-09-26560
K923455HFG 350, 650, 1050Varian Canada, Inc.1992-12-281670
K920938VJW2919 PNEUMATIC COMPRESSION UPGRADEVarian Canada, Inc.1992-06-171110
K913234VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLYVarian Canada, Inc.1991-09-23630
K910820VPW 2877E6 X-RAY POWER SUPPLYVarian Canada, Inc.1991-03-07100
K904169VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLYVarian Canada, Inc.1991-02-191610
K905855VPW2877E7 X RAY POWER SUPPLYVarian Canada, Inc.1991-02-13540

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