Atlas FDA

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

Surgical Appliance Industries, Inc. · Predicate Candidate Screening

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

20 daysmedian FDA review time
42 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K121106TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TSurgical Appliance Industries, Inc.2012-04-27150
K821682TRUNCAL ORTHOSISSurgical Appliance Industries, Inc.1982-06-24160
K813416EXTERNAL BREAST PROSTHESISSurgical Appliance Industries, Inc.1982-01-18420
K812423NEOPRENE KNEE SUPPORTSurgical Appliance Industries, Inc.1981-09-14210
K812422CUSTOM CONTOUR LUMBOSACRAL ORTHOSISSurgical Appliance Industries, Inc.1981-09-14210
K812401CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. OSurgical Appliance Industries, Inc.1981-09-14250
K811690ANKLE-FOOT CAST/SPLINTSurgical Appliance Industries, Inc.1981-06-25100
K811689CYLINDER KNEE CAST/SPLINTSurgical Appliance Industries, Inc.1981-06-25100
K811494LUMBO-SACRAL FLEXION ORTHOSISSurgical Appliance Industries, Inc.1981-06-16200

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