Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BSO — Predicate Candidate Screening
75 FDA 510(k) clearances under this product code; the 50 most recent screened below.
144 daysmedian FDA review time
282 days90th percentile
75clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241410 | EDEN ControlCath | Jmt Co., Ltd. | 2025-02-13 | 272 | 0 |
| K231242 | Perifix FX Catheter; Contiplex FX Catheter | B.Braun Medical, Inc. | 2023-09-15 | 137 | 0 |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow | Teleflex Medical | 2023-08-30 | 180 | 0 |
| K193664 | SubQKath Catheter and Needle Set | Hk Surgical | 2020-09-09 | 253 | 0 |
| K200624 | Percutaneous Introducer | Epimed International, Inc. | 2020-04-27 | 48 | 0 |
| K191470 | C-CAT Anaesthesia Catheter kit | Cimpax Aps | 2019-10-25 | 144 | 0 |
| K181782 | Medline Reinforced Epidural Catheter | Medline Industries, Inc. | 2019-03-04 | 244 | 0 |
| K173541 | EPINAUT | Imedicom Co., Ltd. | 2018-08-24 | 282 | 0 |
| K172777 | Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Ad | PAJUNK GmbH Medizintechnologie | 2018-05-03 | 231 | 0 |
| K171584 | B. Braun Tear-Away Introducer Needle | B.Braun Medical, Inc. | 2017-12-22 | 205 | 0 |
| K171193 | Certa Catheter | Ferrosan Medical Devices Sp. Z.O.O. | 2017-12-18 | 238 | 0 |
| K162522 | UltraCath Continuous Nerve block Catheter | Teleflexmedical, Inc. | 2017-03-17 | 189 | 0 |
| K161232 | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic | Halyard Health | 2016-09-30 | 151 | 0 |
| K153297 | Perifix and Contiplex Catheter | B.Braun Medical, Inc. | 2016-08-12 | 273 | 0 |
| K152952 | E-Cath | PAJUNK GmbH Medizintechnologie | 2016-07-13 | 281 | 0 |
| K150731 | Medline Epidural Catheter | Medline Industries, Inc. | 2016-03-07 | 353 | 0 |
| K150789 | SPINAUT-E, SPINAUT-I | Imedicom Co., Ltd. | 2016-03-01 | 342 | 0 |
| K140110 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERA | Teleflex, Inc. | 2015-03-27 | 436 | 5 |
| K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter S | Kimberly-Clark Corporation | 2014-12-02 | 29 | 0 |
| K133316 | SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODE | Epimed International, Inc. | 2014-05-28 | 212 | 0 |
| K122661 | VITAL 5 RELEAF CATHETER | Vital 5 | 2013-02-27 | 180 | 0 |
| K111031 | PAINFUSOR CATHETER | Plan 1 Health, S.R.L. | 2011-07-08 | 85 | 0 |
| K110814 | AMBIT TUNNELER | Summit Medical Products, Inc. | 2011-04-08 | 15 | 0 |
| K102594 | IO-FLEX CATHETER | Baxano, Inc. | 2011-01-19 | 132 | 0 |
| K102460 | AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH | Summit Medical Products, Inc. | 2011-01-13 | 139 | 0 |
| K093920 | BUSSE EPIDURAL CATHETER KIT | Busse Hospital Disposables | 2010-08-06 | 227 | 0 |
| K090884 | PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. | B.Braun Medical, Inc. | 2009-06-29 | 90 | 0 |
| K081404 | SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHET | Spinal Integration, LLC | 2008-10-21 | 155 | 0 |
| K080675 | PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT | PAJUNK GmbH Medizintechnologie | 2008-06-20 | 102 | 0 |
| K072702 | STRYKER ANTIMIC CATHETER | Stryker Instruments, Instruments Div. | 2008-03-19 | 177 | 0 |
| K072050 | PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS | Life-Tech, Inc. | 2007-10-18 | 84 | 0 |
| K070465 | BUSSE EPIDURAL CATHETER | Busse Hospital Disposables, Inc. | 2007-07-19 | 153 | 0 |
| K063234 | ON-Q INTRODUCERS | I-Flow Corp. | 2006-11-21 | 27 | 0 |
| K062005 | PORTEX EPIDURAL CATHETER | Smiths Medical Asd, Inc. | 2006-10-18 | 93 | 1 |
| K051401 | ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I | I-Flow Corp. | 2005-11-30 | 183 | 0 |
| K051524 | LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, | Smiths Medical Asd, Inc. | 2005-07-07 | 29 | 0 |
| K050557 | AMT NANOCATH | American Medical Technologies, Inc. | 2005-05-27 | 85 | 0 |
| K043456 | MODIFICATION TO SOAKER CATHETER | I-Flow Corp. | 2005-01-11 | 27 | 0 |
| K042488 | PERIFIX CATHETER AND CONTIPLEX CATHETER | B.Braun Medical, Inc. | 2004-09-30 | 17 | 0 |
| K032390 | MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHE | Ebi, L.P. | 2003-08-29 | 25 | 0 |
| K023140 | VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 | Epimed International, Inc. | 2003-08-15 | 329 | 0 |
| K023233 | EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM | Ebi, L.P. | 2002-12-13 | 77 | 1 |
| K022019 | PERIFIX CATHETER CONNECTOR | B.Braun Medical, Inc. | 2002-08-01 | 42 | 0 |
| K991259 | TE ME NA EPIDURAL CATHETER | Te ME NA S.A.R.L. | 2001-02-21 | 680 | 0 |
| K000886 | SPIROL EPIDURAL CATHETER | Abbott Laboratories | 2000-10-05 | 199 | 0 |
| K001717 | MICOR CONDUCTION CATHETER | Micor, Inc. | 2000-09-20 | 107 | 0 |
| K993592 | AXIOM MULTIPURPOSE WOUND DRAIN | Axiom Medical, Inc. | 2000-05-17 | 208 | 0 |
| K991879 | SPRING-WOUND EPIDURAL CATHETER | Micor, Inc. | 1999-10-28 | 148 | 0 |
| K992471 | SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MO | Sims Portex, Inc. | 1999-10-22 | 88 | 0 |
| K981329 | FETH-R-KATH | Epimed International, Inc. | 1998-08-26 | 135 | 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