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

Aries Medical, Inc. · Predicate Candidate Screening

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

130 daysmedian FDA review time
214 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K912604SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIFAries Medical, Inc.1991-10-281500
K903925ARIES MELDICAL MODEL 2100HC HANK CRANKAries Medical, Inc.1990-12-211300
K903442ARIES TAPERSEAL(TM) SHEATHAries Medical, Inc.1990-08-23230
K895433ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYSAries Medical, Inc.1990-04-102150
K882289ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.Aries Medical, Inc.1988-12-121940
K86499440CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETERAries Medical, Inc.1987-06-191790
K86453740CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETERAries Medical, Inc.1987-06-192140
K86456740CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETERAries Medical, Inc.1987-05-121740
K86456840CC SURGICAL DOUBLE LUMEN BALLOON CATHETERAries Medical, Inc.1987-05-121740
K871140ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCERAries Medical, Inc.1987-04-22300
K870189ARIES TAPERED SHEATHAries Medical, Inc.1987-03-16590
K86318540CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOONAries Medical, Inc.1987-01-161500
K844220ARIES MEDICAL PERFLEX PERCUTANEOUS 40CC D/L BALLOOAries Medical, Inc.1985-02-201120
K850111AIRES TUOHY NEEDLES 17GA. X 4 1/2Aries Medical, Inc.1985-01-24100
K842004PERCUTANEOUS CATHETER INTRODUCER SETAries Medical, Inc.1984-07-13580
K833632ARIES MEDICAL MODEL 700Aries Medical, Inc.1984-05-162120
K840201EPIDURAL CATHETER TRAYAries Medical, Inc.1984-03-02430
K840202EPIDURAL CATHETERAries Medical, Inc.1984-02-27390
K840641VESSEL DILATORAries Medical, Inc.1984-02-1400

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