Atlas FDA

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

Phoenix Medical Technology, Inc. · Predicate Candidate Screening

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

71 daysmedian FDA review time
154 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K000223NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREEPhoenix Medical Technology, Inc.2000-04-14810
K945045PATIENT EXAINATION GLOVESPhoenix Medical Technology, Inc.1995-01-02800
K905031PATIENT EXAMINATION GLOVESPhoenix Medical Technology, Inc.1991-01-18720
K900454MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVESPhoenix Medical Technology, Inc.1990-02-13140
K900453MODIFIED SINGLE USE LATEX EXAMINATION GLOVESPhoenix Medical Technology, Inc.1990-02-13140
K890917PHOENIX DRAPES WITH MICROBANPhoenix Medical Technology, Inc.1989-08-171750
K892976SINGLE USE VINYL EXAM GLOVES - COLOR CODEDPhoenix Medical Technology, Inc.1989-06-22710
K892975LOW POWDER SINGLE USE LATEX EXAM GLOVESPhoenix Medical Technology, Inc.1989-06-19680
K891949PATIENT EXAMINATION GLOVES (LATEX)Phoenix Medical Technology, Inc.1989-05-25580
K891132PATIENT EXAMINATION GLOVEPhoenix Medical Technology, Inc.1989-03-22190
K853993DOBE (MODIFIED)Phoenix Medical Technology, Inc.1986-02-281540

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