Atlas FDA

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

Angiosystems, Inc. — Predicate Candidate Screening

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

63 daysmedian FDA review time
121 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K905464MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLINGAngiosystems, Inc.1991-05-311770
K905459SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOMAngiosystems, Inc.1991-04-051210
K905461PROCEDURE KIT/ROUTINE DENTAL PROCEDURESAngiosystems, Inc.1991-03-05900
K905466STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPEAngiosystems, Inc.1991-02-11680
K905465STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPEAngiosystems, Inc.1991-02-11680
K905460STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERYAngiosystems, Inc.1991-02-06630
K905462PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURESAngiosystems, Inc.1991-02-06630
K905463GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATIONAngiosystems, Inc.1991-01-22480
K864688ARNOLD-KING PRESSURE DRESSINGAngiosystems, Inc.1987-01-12410
K843259ANGIO SYS FLUOROSCOPE DRAPEAngiosystems, Inc.1984-09-21320
K843258ANGIO SYS BRACHIAL ANGIO DRAPEAngiosystems, Inc.1984-09-21320
K843260ANGIOSYS FEMORAL ANGIOGRAPHY DRAPEAngiosystems, Inc.1984-09-21320
K843257ANGIO SYS STERILE FIELD COVERAngiosystems, Inc.1984-09-21320
K843261ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARDAngiosystems, Inc.1984-09-11220

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