Atlas FDA

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

Angiomed U.S., Inc. · Predicate Candidate Screening

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

54 daysmedian FDA review time
95 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K874771ANGIOMED INTRODUCING SETSAngiomed U.S., Inc.1988-01-12540
K874585ANGIOMED OSTY-CUT BONE BIOPSY NEEDLEAngiomed U.S., Inc.1987-12-02230
K864225ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENTAngiomed U.S., Inc.1987-01-30940
K863386VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETSAngiomed U.S., Inc.1986-10-24510
K862805ANGIOMED VAC-U-CUT BIOPSY NEEDLEAngiomed U.S., Inc.1986-09-29690
K863446ANGIOMED HIGH PRESSURE CONNECTORSAngiomed U.S., Inc.1986-09-23150
K854910ANGIOFLOWAngiomed U.S., Inc.1986-07-172200
K854912ANGIOMED GUIED WIRESAngiomed U.S., Inc.1986-04-161280
K854908UROFLEXAngiomed U.S., Inc.1986-03-14950
K855143ANGIOMED EXCHANGE DRAINAGE CATHETER SETSAngiomed U.S., Inc.1986-03-11750
K855076ANGIOMED URETER DIATION SETSAngiomed U.S., Inc.1986-03-11820
K855142ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHYAngiomed U.S., Inc.1986-03-11750
K860534BILE ENDOPROSTHESIS SETAngiomed U.S., Inc.1986-03-10260
K855140ANGIOMED RENAL DILATION SETAngiomed U.S., Inc.1986-02-24600
K855078ANGIO MED DISPOSABLE PRESSURE CONNECTORSAngiomed U.S., Inc.1986-02-19620
K854652ANGIOMED URETERAL STONE DISLODGERSAngiomed U.S., Inc.1986-02-10830
K854911PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER)Angiomed U.S., Inc.1986-01-24460
K854909PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETSAngiomed U.S., Inc.1986-01-24460
K855141ANGIOMED FINE NEEDLES AND NEEDLE SETAngiomed U.S., Inc.1986-01-24290
K854905PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE)Angiomed U.S., Inc.1986-01-24460
K854906PERCUTANEOUS NEPHROSTOMY SETS (OTTO)Angiomed U.S., Inc.1986-01-2400
K854907PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)Angiomed U.S., Inc.1986-01-24460
K855104ANGIOMED SKIN FASCIA KNIFEAngiomed U.S., Inc.1986-01-24320
K855077ANGIOMED HARZMANN DISCSAngiomed U.S., Inc.1986-01-21330

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