Atlas FDA

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

Advance Medical Designs, Inc. · Predicate Candidate Screening

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

73 daysmedian FDA review time
358 days90th percentile
32clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K223689Disposable Needle Guides and GridsAdvance Medical Designs, Inc.2023-08-022360
K163050Advance Medical Designs, Inc. Sterile Ultrasound GelAdvance Medical Designs, Inc.2017-10-253580
K053495EQUIPMENT SLUSH DRAPEAdvance Medical Designs, Inc.2006-03-16910
K011265ULTRASOUND TRANSDUCER COVERAdvance Medical Designs, Inc.2001-10-301880
K012168ADVANCE MEDICAL DESIGNS FLUID POUCHAdvance Medical Designs, Inc.2001-09-18680
K011422SURGICAL DRAPESAdvance Medical Designs, Inc.2001-07-10620
K003670PATIENT DRAPE, SURGICALAdvance Medical Designs, Inc.2001-01-26590
K925115AMD DENTIST AND HYGIENIST KITSAdvance Medical Designs, Inc.1994-07-056340
K911884ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINESAdvance Medical Designs, Inc.1994-07-0511630
K915301ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCKAdvance Medical Designs, Inc.1992-12-113860
K911732ADVANCE DISPOSABLE CONTROL SYRINGEAdvance Medical Designs, Inc.1991-09-161523
K904601ADVANCE DISPOSABLE PRESSURE TRANSDUCERAdvance Medical Designs, Inc.1990-12-17680
K902724ADVANCE DISPOSABLE STOPCOCKAdvance Medical Designs, Inc.1990-12-051670
K903358ADVANCE LAPAROTOMY SPONGE, LAP SPONGEAdvance Medical Designs, Inc.1990-11-291260
K902346DISPOSABLE CORONARY CONTROL SYRINGEAdvance Medical Designs, Inc.1990-06-26320
K900187ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH)Advance Medical Designs, Inc.1990-05-011050
K900188ADVANCE ADMINISTRATION SETS (VARYING LENGTH)Advance Medical Designs, Inc.1990-05-011050
K897196ADVANCE STOPCOCKS ADVANCE MANIFOLDSAdvance Medical Designs, Inc.1990-03-27880
K897197ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.Advance Medical Designs, Inc.1990-03-19800
K896076L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R)Advance Medical Designs, Inc.1990-01-04770
K895454SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK)Advance Medical Designs, Inc.1989-11-14700
K895455SELDINGER PERCUTANEOUS 2 PC NEEDLESAdvance Medical Designs, Inc.1989-11-14700
K8958452018 ARTERIAL/VENOUS PRESSURE DRESSINGAdvance Medical Designs, Inc.1989-11-01290
K895457MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLESAdvance Medical Designs, Inc.1989-11-01570
K895453SPINAL NEEDLEAdvance Medical Designs, Inc.1989-10-19440
K89480130-CS01, 30-CS02, 30-CS03 CONTROL SYRINGESAdvance Medical Designs, Inc.1989-09-19530
K894764OR TOWEL PACKSAdvance Medical Designs, Inc.1989-08-18220
K852893VIAL DECANTERAdvance Medical Designs, Inc.1985-09-20730
K853188TRANSFER DEVICEAdvance Medical Designs, Inc.1985-08-21220
K852777BAG DECANTERAdvance Medical Designs, Inc.1985-08-16460
K852778BOTTLE DECANTERAdvance Medical Designs, Inc.1985-08-16460
K850959EQUIPMENT SNAP KOVERSAdvance Medical Designs, Inc.1985-04-09321

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