Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CAZ — Predicate Candidate Screening
155 FDA 510(k) clearances under this product code; the 50 most recent screened below.
108 daysmedian FDA review time
272 days90th percentile
155clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222341 | Arrow 0.2 Micron Flat Filter, GVS | Arrow International, LLC | 2023-02-13 | 194 | 0 |
| K210983 | BD Epilor Syringe | Becton, Dickinson and Company | 2022-05-19 | 413 | 0 |
| K201356 | Plastic LOR Syringe | Jiangsu Caina Medical Co.,Ltd | 2021-02-12 | 267 | 0 |
| K202699 | E-Cath STIM acc. Tsui | PAJUNK GmbH Medizintechnologie | 2020-12-29 | 104 | 0 |
| K190345 | VPC | PAJUNK GmbH Medizintechnologie | 2019-05-16 | 91 | 0 |
| K161075 | Arrow Epidural Catheter Kit | Teleflexmedical, Inc. | 2016-10-04 | 169 | 0 |
| K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter K | Teleflex, Inc. | 2016-06-21 | 183 | 0 |
| K143581 | Arrow Epidural Catheter Kit | Teleflexmedical, Inc. | 2015-06-26 | 190 | 0 |
| K122690 | ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE | Arrow International, Inc. | 2012-12-21 | 108 | 0 |
| K110053 | CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INF | Smiths Medical Asd, Inc. | 2012-09-14 | 616 | 0 |
| K122027 | ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER | Arrow International, Inc. | 2012-08-28 | 48 | 1 |
| K121525 | PERIFUSE CATHETER | Smiths Medical Asd, Inc. | 2012-08-02 | 71 | 0 |
| K121403 | CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET | Teleflex, Inc. | 2012-06-20 | 41 | 3 |
| K103658 | FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER | Teleflex, Inc. | 2012-05-16 | 518 | 3 |
| K113662 | FENESTRATED NERVE BLOCK NEEDLE | Imd, Inc. | 2012-04-20 | 135 | 0 |
| K113188 | SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO | PAJUNK GmbH Medizintechnologie | 2012-03-01 | 122 | 0 |
| K113059 | CONTIPLEX FX | B.Braun Medical, Inc. | 2012-01-24 | 102 | 0 |
| K111355 | ECHOBRIGHT | Life-Tech, Inc. | 2011-09-16 | 123 | 0 |
| K102007 | PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150T | Life-Tech, Inc. | 2010-12-22 | 159 | 0 |
| K093662 | ECHOBRIGHT | Life-Tech, Inc. | 2010-06-24 | 211 | 0 |
| K092657 | EPIFUSE CATHETER CONNECTOR, MODEL: 4909E | Smiths Medical Asd, Inc. | 2009-11-04 | 68 | 0 |
| K090995 | B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET | B.Braun Medical, Inc. | 2009-08-14 | 129 | 0 |
| K082183 | PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: C | PAJUNK GmbH Medizintechnologie | 2008-10-28 | 88 | 0 |
| K082164 | PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF | PAJUNK GmbH Medizintechnologie | 2008-10-27 | 88 | 0 |
| K080804 | BUSSE PLASTIC LOR SYRINGE | Busse Hosipital Disposables | 2008-07-09 | 110 | 0 |
| K073187 | PERIPHERAL NERVE BLOCK SUPPORT TRAY | Life-Tech, Inc. | 2008-04-22 | 161 | 0 |
| K063282 | CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET | B.Braun Medical, Inc. | 2007-06-20 | 232 | 0 |
| K062902 | PAJUNKS EPILONG SET PEDIATRIC | PAJUNK GmbH Medizintechnologie | 2007-06-07 | 253 | 0 |
| K063018 | GLASS LOSS OF RESISTANCE SYRINGE | Busse Hospital Disposables, Inc. | 2007-01-22 | 112 | 0 |
| K062900 | PAJUNKS STIMULONG TSUI-METHOD SET | PAJUNK GmbH Medizintechnologie | 2007-01-12 | 107 | 0 |
| K061737 | LOSS OF RESISTANCE SYRINGE | Robert Busse & Co., Inc. | 2006-12-18 | 181 | 0 |
| K060186 | POLYPLEX STIMULATING CATHETER SYSTEM | Te ME NA Sas | 2006-07-18 | 175 | 0 |
| K060311 | EPILONG KIT FOR ANESTHESIOLOGY | PAJUNK GmbH Medizintechnologie | 2006-06-13 | 125 | 0 |
| K060563 | EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN I | Pajunk GmbH | 2006-06-02 | 114 | 0 |
| K052954 | CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET | Life-Tech, Inc. | 2006-02-15 | 118 | 0 |
| K053283 | UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG | Pajunk GmbH | 2006-01-12 | 48 | 0 |
| K052946 | MPS ACACIA NERVE BLOCK NEEDLE | Mps Acacia | 2005-12-08 | 49 | 0 |
| K051171 | STINGRAY EPIDURAL CATHETER CONNECTOR | Epimed International, Inc. | 2005-08-26 | 112 | 1 |
| K043130 | MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS | Pajunk GmbH | 2004-12-21 | 39 | 0 |
| K041158 | ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS | Atrion Medical Products, Inc. | 2004-06-16 | 44 | 0 |
| K033018 | STIMULONG PLUS CATHETER SET MODEL, VARIOUS | Pajunk GmbH | 2004-05-05 | 222 | 0 |
| K033080 | PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESI | Portex, Inc. | 2004-03-10 | 163 | 0 |
| K033952 | PERIFIX CATHETER CONNECTOR | B.Braun Medical, Inc. | 2004-02-04 | 44 | 0 |
| K031128 | B-SMART, MODEL B-01 | Macosta Medical USA, LLC | 2004-01-15 | 281 | 0 |
| K032144 | PERIFIX CATHETER CONNECTOR | B.Braun Medical, Inc. | 2003-10-01 | 79 | 0 |
| K022752 | PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18- | Hdc Corp. | 2003-09-09 | 386 | 0 |
| K030937 | STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02 | Arrow International, Inc. | 2003-04-23 | 29 | 1 |
| K014246 | AVID-NIT NERVE STIMULATION NEEDLES | Avid N.I.T., Inc. | 2002-07-16 | 202 | 0 |
| K021567 | STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-0500 | Arrow Intl., Inc. | 2002-06-19 | 37 | 2 |
| K013041 | PLEXOLONG SETS | Pajunk GmbH | 2002-06-11 | 274 | 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