Atlas FDA

PND

13 FDA 510(k) clearances · Product code

159 daysmedian time to decision
231 days90th percentile
13clearances measured

FDA profile

Official device name
Midline Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5200
Medical specialty
General Hospital
FDA definition
The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.
Adverse events (MAUDE)
2021: 86 · 2022: 178 · 2023: 138 · 2024: 168 · 2025: 145 · 2026: 69
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Midline Catheter (K252402)Terumo Medical Products (Hangzhou) Co., Ltd.2025-12-18
Arrow Pressure Injectable Midline Catheter (K213855)Arrow International, LLC Subsidiary of Teleflex Incorporated2022-09-02
Provena(TM) Midline Catheter (K213203)C.R. Bard, Inc.2022-05-13
Stiletto Extended Dwell Catheter (K210047)Piper Access, LLC2021-08-27
primeMidline Catheters (K192802)Pfm Medical, Inc.2019-10-28
Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter (K181208)Vygon USA2018-11-02
primeMidline Catheters (K173114)Pfm Medical, Inc.2018-03-07
ArchFlo CT Midline (K171483)Medcomp (Dba Medical Components, Inc.)2017-12-15
CT Midline (K170770)Medical Components, Inc. (dba MedComp)2017-07-25
PowerGlide ST Midline Catheter (K170158)C.R. Bard, Inc.2017-06-01
PowerMidline Catheter (K162900)C.R. Bard, Inc.2016-12-14
ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K161313)Arrow International, Inc. (Subsidiary of Teleflex, Inc.)2016-08-24
PowerMidline Catheter (K153393)C.R. Bard, Inc.2016-06-28

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Every clearance here is in the API, with alerts when new ones post.