Atlas FDA

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

Stanco Medical, Inc. · Predicate Candidate Screening

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

18 daysmedian FDA review time
62 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K810643UNIVERSAL PACING ELECTRODE KITStanco Medical, Inc.1981-04-08290
K810642ATRIAL-VENTRICULAR PACING ELECTRODE KITStanco Medical, Inc.1981-04-08290
K802289PERICARDIOCENTESIS KITStanco Medical, Inc.1980-11-26680
K802287RIGHT ATRIAL LINE KITStanco Medical, Inc.1980-11-20620
K802288SWAN GANZ CATHETER PLACEMENT KITStanco Medical, Inc.1980-11-20620
K802259TRANSVENOUS PACEMAKER ELECTRODE KITStanco Medical, Inc.1980-10-23370
K802290REGIONAL INTRAVENOUS ANESTHESIA KITStanco Medical, Inc.1980-10-17280
K802327SHEATH DILATOR SETStanco Medical, Inc.1980-10-10170
K802260VASCULAR CATHETER WIREGUIDESStanco Medical, Inc.1980-10-10240
K802326PRESSURE MONITORING LINESStanco Medical, Inc.1980-10-10170
K802328DISP. TOUGY-BORST TYPE ADAPTOR W/PORTStanco Medical, Inc.1980-10-10170
K802261PRESSURE GAUGE ACCESSORY KIT/DILATATIONStanco Medical, Inc.1980-10-03170
K802329DISPOSABLE CONSTRAST DELIVERY SPIKE KITStanco Medical, Inc.1980-10-03100
K802258STOPCOCK 2-WAY, 3-WAY & 4-WAYStanco Medical, Inc.1980-09-26100
K792131TEMPORARY TRANSVENOUS PACMKER. ELECTRODEStanco Medical, Inc.1979-11-13180
K792130TRANSVENOUS BALLOON CATH. INTRO. KITStanco Medical, Inc.1979-11-13180
K792170PERCUTANEOUS SHEATH (MULTI-CATH)SIDEStanco Medical, Inc.1979-11-13150
K792172PERCUTANEOUS SHEATH INTRO. KIT OR TRAYStanco Medical, Inc.1979-11-13150
K792171COMPLETE TRAY CENTRAL VENOUS PRESSUREStanco Medical, Inc.1979-11-13150

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