Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Myco Medical Supplies, Inc. · Predicate Candidate Screening

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

308 daysmedian FDA review time
503 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K203668RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles,Myco Medical Supplies, Inc.2021-09-292870
K173279RELI Safety Blood Collection Tube Holder, RELI Blood CollectMyco Medical Supplies, Inc.2018-05-142130
K090426VAKU-8 BLOOD COLLECTION NEEDLESMyco Medical Supplies, Inc.2009-06-121130
K042504CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETERMyco Medical Supplies, Inc.2006-01-194910
K000592UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SEMyco Medical Supplies, Inc.2001-04-124150
K990519PHOENIX EPIDURAL & SPINAL NEEDLESMyco Medical Supplies, Inc.2000-06-024700
K982646AILEE SUTURES AND AILEE NEEDLESMyco Medical Supplies, Inc.1999-06-023080
K990388TUTOPLUS IV ADMINISTRATION SETMyco Medical Supplies, Inc.1999-03-29490
K982098TUTODROP 1 AND TUTODROP 2Myco Medical Supplies, Inc.1999-03-012590
K963364GLASS VAN GLASS SYRINGESMyco Medical Supplies, Inc.1998-05-016130
K953252DISPOSABLE SCALP VEIN INFUSION SETMyco Medical Supplies, Inc.1996-11-265030
K945225DISPOSABLE SYRINGES AND DISPOSABLE NEEDLESMyco Medical Supplies, Inc.1995-01-26921

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