Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
B.Braun Medical, Inc. · Predicate Candidate Screening
149 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
289 days90th percentile
149clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253235 | Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. | 2026-05-15 | 228 | 0 |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Set | B.Braun Medical, Inc. | 2025-07-24 | 266 | 0 |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertib | B.Braun Medical, Inc. | 2024-07-31 | 152 | 0 |
| K241845 | Introcan Safety® 2 IV Catheter | B.Braun Medical, Inc. | 2024-07-26 | 30 | 0 |
| K241385 | Omnifix Syringe NRFit | B.Braun Medical, Inc. | 2024-07-13 | 59 | 0 |
| K231242 | Perifix FX Catheter; Contiplex FX Catheter | B.Braun Medical, Inc. | 2023-09-15 | 137 | 0 |
| K223479 | AQUAbase nX | B.Braun Medical, Inc. | 2023-08-16 | 271 | 0 |
| K220756 | Introcan Safety 2 IV Catheter | B.Braun Medical, Inc. | 2022-06-23 | 100 | 0 |
| K220626 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2022-05-14 | 71 | 0 |
| K213778 | IV Administration Set | B.Braun Medical, Inc. | 2022-03-03 | 90 | 0 |
| K213664 | B. Braun Introcan Safety 2 IV Catheter | B.Braun Medical, Inc. | 2022-02-11 | 81 | 0 |
| K212842 | Microvolume Luer Access Device | B.Braun Medical, Inc. | 2022-01-18 | 133 | 0 |
| K213085 | Introcan Safety 3 Closed IV Catheter | B.Braun Medical, Inc. | 2021-10-25 | 31 | 1 |
| K202618 | IV Administration Sets | B.Braun Medical, Inc. | 2021-09-24 | 379 | 1 |
| K201469 | Mini Spike Plus 6/8R | B.Braun Medical, Inc. | 2020-12-09 | 189 | 0 |
| K192577 | Actreen Hi-Lite Intermittent Urinary Catheters | B.Braun Medical, Inc. | 2020-05-07 | 231 | 0 |
| K192676 | Introcan Safety 2 IV Catheter 18-24 gauge | B.Braun Medical, Inc. | 2020-04-01 | 188 | 0 |
| K191658 | IV Sets not made with PVC | B.Braun Medical, Inc. | 2020-03-19 | 272 | 1 |
| K193101 | Omnifix Low Dead Space Luer Lock Syringe | B.Braun Medical, Inc. | 2020-03-05 | 118 | 0 |
| K182870 | Introcan Safety 3 Closed IV Catheter | B.Braun Medical, Inc. | 2019-03-07 | 146 | 1 |
| K180801 | Actreen Hi-Lite Cath, Actreen Hi-Lite Set | B.Braun Medical, Inc. | 2018-11-05 | 222 | 0 |
| K173531 | Lockbox for Perfusor Space PCA Infusion Pump | B.Braun Medical, Inc. | 2018-08-02 | 260 | 0 |
| K173361 | IV Administration Set | B.Braun Medical, Inc. | 2018-06-26 | 243 | 0 |
| K172831 | Perfusor® Space Syringe Infusion Pump System | B.Braun Medical, Inc. | 2018-06-12 | 267 | 3 |
| K173803 | Omnican fine | B.Braun Medical, Inc. | 2018-06-11 | 178 | 0 |
| K171584 | B. Braun Tear-Away Introducer Needle | B.Braun Medical, Inc. | 2017-12-22 | 205 | 0 |
| K170595 | IV Administration Sets | B.Braun Medical, Inc. | 2017-11-07 | 252 | 19 |
| K170897 | Surecan Safety II Needle, Surecan Safety II Needle, Surecan | B.Braun Medical, Inc. | 2017-11-03 | 221 | 0 |
| K163430 | Prontosan Wound Gel | B.Braun Medical, Inc. | 2017-05-23 | 167 | 0 |
| K161623 | Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound | B.Braun Medical, Inc. | 2016-11-10 | 150 | 0 |
| K153297 | Perifix and Contiplex Catheter | B.Braun Medical, Inc. | 2016-08-12 | 273 | 0 |
| K153293 | Extension Set | B.Braun Medical, Inc. | 2016-04-06 | 145 | 7 |
| K151423 | APEX Compounding System Transfer Set | B.Braun Medical, Inc. | 2016-02-19 | 267 | 0 |
| K151772 | Actreen Mini Intermittent Urinary Catheters | B.Braun Medical, Inc. | 2016-02-09 | 224 | 0 |
| K150787 | Universal Spike | B.Braun Medical, Inc. | 2015-12-02 | 252 | 0 |
| K150800 | Valved Safety Centesis Catheter | B.Braun Medical, Inc. | 2015-11-12 | 231 | 0 |
| K143082 | IV Administration Sets with 200(micro)m Blood Filter | B.Braun Medical, Inc. | 2015-07-24 | 270 | 0 |
| K142596 | Infusomat Space Volumetric Infusion Pump | B.Braun Medical, Inc. | 2015-06-18 | 276 | 2 |
| K140838 | IV ADMINISTRATION SET WITH HAND PUMP | B.Braun Medical, Inc. | 2014-12-05 | 247 | 0 |
| K142036 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS | B.Braun Medical, Inc. | 2014-08-25 | 28 | 29 |
| K133632 | PERICAN ULTRA | B.Braun Medical, Inc. | 2014-06-27 | 213 | 0 |
| K140311 | CARESITE LUER ACCESS DEVICE | B.Braun Medical, Inc. | 2014-05-07 | 89 | 14 |
| K130857 | PRONTOSAN WOUND GEL X | B.Braun Medical, Inc. | 2013-10-08 | 194 | 0 |
| K131842 | STERICAN CANNULA | B.Braun Medical, Inc. | 2013-08-20 | 60 | 0 |
| K121846 | CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE | B.Braun Medical, Inc. | 2012-11-20 | 148 | 0 |
| K120150 | DUAL SPIKE TRANSFER DEVICE | B.Braun Medical, Inc. | 2012-05-24 | 127 | 0 |
| K113059 | CONTIPLEX FX | B.Braun Medical, Inc. | 2012-01-24 | 102 | 0 |
| K112515 | PENCAN SPINAL NEEDLE | B.Braun Medical, Inc. | 2011-12-22 | 114 | 0 |
| K112636 | CYTOGUARD(TM) CLOSED LUER CONNECTOR | B.Braun Medical, Inc. | 2011-11-26 | 78 | 0 |
| K110744 | PRONTOSAN WOUND IRRIGATION SOLUTION | B.Braun Medical, Inc. | 2011-04-06 | 20 | 0 |
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