Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PND — Predicate Candidate Screening
13 FDA 510(k) clearances under this product code; the 50 most recent screened below.
159 daysmedian FDA review time
231 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252402 | Midline Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-18 | 140 | 0 |
| K213855 | Arrow Pressure Injectable Midline Catheter | Arrow International, LLC Subsidiary of Teleflex Incorporated | 2022-09-02 | 266 | 1 |
| K213203 | Provena(TM) Midline Catheter | C.R. Bard, Inc. | 2022-05-13 | 226 | 1 |
| K210047 | Stiletto Extended Dwell Catheter | Piper Access, LLC | 2021-08-27 | 231 | 0 |
| K192802 | primeMidline Catheters | Pfm Medical, Inc. | 2019-10-28 | 28 | 0 |
| K181208 | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Cathet | Vygon USA | 2018-11-02 | 179 | 0 |
| K173114 | primeMidline Catheters | Pfm Medical, Inc. | 2018-03-07 | 159 | 0 |
| K171483 | ArchFlo CT Midline | Medcomp (Dba Medical Components, Inc.) | 2017-12-15 | 207 | 0 |
| K170770 | CT Midline | Medical Components, Inc. (dba MedComp) | 2017-07-25 | 133 | 0 |
| K170158 | PowerGlide ST Midline Catheter | C.R. Bard, Inc. | 2017-06-01 | 134 | 0 |
| K162900 | PowerMidline Catheter | C.R. Bard, Inc. | 2016-12-14 | 58 | 1 |
| K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-08-24 | 106 | 1 |
| K153393 | PowerMidline Catheter | C.R. Bard, Inc. | 2016-06-28 | 217 | 1 |
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