Atlas FDA

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

Axiom Medical, Inc. — Predicate Candidate Screening

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

69 daysmedian FDA review time
208 days90th percentile
28clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K993592AXIOM MULTIPURPOSE WOUND DRAINAxiom Medical, Inc.2000-05-172080
K971851INTERPLEURAL ANESTHESIA CATHETERAxiom Medical, Inc.1998-01-222470
K965146FLAT CLOSED WOUND DRAIN WITH TROCARAxiom Medical, Inc.1997-03-10770
K934895GLASSMAN SILICONE CATHETERAxiom Medical, Inc.1994-10-133730
K922760ATRAUM WOUND DRESSING--MODIFICATIONAxiom Medical, Inc.1992-10-301550
K905422PVC ROUND WOUND DRAINSAxiom Medical, Inc.1991-02-11690
K904218SUCTION SYSTEMAxiom Medical, Inc.1990-10-31490
K904133DISPOSABLE FLUID COLLECTION BAGAxiom Medical, Inc.1990-10-11350
K863247AXIOM TROCAR THORACIC CATHETERAxiom Medical, Inc.1986-08-2970
K861306SUCTION SYSTEMAxiom Medical, Inc.1986-06-09620
K852614ATRAUM WOUND DRESSINGAxiom Medical, Inc.1985-08-30710
K852241AXIOM ATRAUM TROCAR CATHETERAxiom Medical, Inc.1985-06-14220
K841574QUAZAR ESOPHAGEAL STETHOSCOPEAxiom Medical, Inc.1984-08-151200
K842084AXIOM FEMORAL VENUS CATHETERAxiom Medical, Inc.1984-08-01690
K841593AXIOM THORACIC CATHETERSAxiom Medical, Inc.1984-06-05480
K832476SILICONE SOFT-PAK EPISTAXIS CATHETERAxiom Medical, Inc.1983-11-031000
K832416AXIOM HYDROMER WOUND DRAINSAxiom Medical, Inc.1983-10-311020
K832475AXIOM PERFUSSION CANNULAAxiom Medical, Inc.1983-10-19850
K831823AXIOM FEEDING GASTRO TUBEAxiom Medical, Inc.1983-08-12660
K820161AXIOM LIG-A-BOOTSAxiom Medical, Inc.1982-03-15540
K800015AXIOM VESSEL LOOPSAxiom Medical, Inc.1980-03-25810
K791509AXIOM GASTRO SUMP DRAINAxiom Medical, Inc.1979-09-04340
K791508AXIOM FILTERED CONNECTORAxiom Medical, Inc.1979-09-04340
K781749TUBING, AXIOM SILICONE PENROSEAxiom Medical, Inc.1978-12-04480
K771022CATHETER, UMBILICAR ARTERYAxiom Medical, Inc.1977-11-291760
K770983CATHETER THORACIC, AXIOMAxiom Medical, Inc.1977-07-29590
K771048CATHETERS, DRAINAGEAxiom Medical, Inc.1977-07-19390
K771021AUTO-CLIPAxiom Medical, Inc.1977-06-1480

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