Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FIE — Predicate Candidate Screening
80 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
302 days90th percentile
80clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253469 | Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 3 | Mozarc Medical Us, LLC | 2026-08-06 | 300 | 0 |
| K251877 | JMS CAVEO A.V. Fistula Needle Set | JMS North America Corporation | 2025-08-15 | 58 | 0 |
| K213015 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2022-04-08 | 200 | 0 |
| K171505 | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) | Dimesol, Inc. | 2018-05-17 | 359 | 0 |
| K163025 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017-07-20 | 262 | 0 |
| K151017 | JMS Harmony A.V. Fistula Needle Set | JMS North America Corporation | 2015-05-13 | 27 | 0 |
| K131950 | ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET | Summit International Medical Technologies, Inc. | 2015-01-16 | 568 | 0 |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MIN | JMS North America Corporation | 2014-12-23 | 103 | 0 |
| K134019 | MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI- | Nxstage Medical, Inc. | 2014-09-11 | 255 | 0 |
| K112734 | APLAN A.V. FISTULA NEEDLE SET | Aplan Well Enterprise Co., Ltd. | 2012-04-24 | 217 | 0 |
| K112178 | JMS APHERESIS NEEDLE SET WINGEATER(R) V2 | JMS North America Corporation | 2011-10-27 | 91 | 0 |
| K111948 | WINGEATER V2 | JMS North America Corporation | 2011-10-24 | 108 | 0 |
| K110157 | SYSLOC MINI V3 | JMS North America Corporation | 2011-02-11 | 23 | 0 |
| K100520 | NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER | Nipro Medical Corporation | 2010-03-17 | 22 | 0 |
| K093637 | JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOO | Jms North America Corp. | 2010-02-09 | 77 | 0 |
| K093985 | NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE | Nipro Medical Corp. | 2010-01-22 | 29 | 0 |
| K082882 | A.V. FISTULA BLUNT NEEDLE SET | Jms North America Corp. | 2009-01-21 | 113 | 0 |
| K062953 | MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREME | Medisystems Corp. | 2007-02-12 | 136 | 0 |
| K063368 | NIPRO BIOHOLE NEEDLE | Nipro Medical Corp. | 2007-02-05 | 90 | 0 |
| K063721 | NIPRO SAFETOUCH II GAMMA | Nipro Medical Corp. | 2007-01-12 | 28 | 0 |
| K052267 | SUPERCATH V | Togo Medikit Co., Ltd. | 2006-10-27 | 434 | 0 |
| K051814 | JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE | Jms North America Corp. | 2005-08-04 | 30 | 0 |
| K040247 | PLUME SAFETY AVF NEEDLE | Jms North America Corp. | 2004-03-03 | 29 | 0 |
| K023162 | FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS | Fresenius Medical Care | 2003-03-20 | 178 | 0 |
| K013384 | SHARGHP A.V. FISTULA NEEDLE SET | Shargh Pharmaceutical Co., Inc. | 2002-01-07 | 87 | 0 |
| K013037 | EXCEL A.V FISUTAL NEEDLE SET | Exelint Intl. Co. | 2001-12-07 | 88 | 0 |
| K002352 | JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE | Jms Co., Ltd. | 2001-09-06 | 400 | 0 |
| K003123 | RENAX A.V. FISTULA NEEDLE SETS | Sunder Biomedical Tech. Co., Ltd. | 2001-05-04 | 211 | 0 |
| K002813 | NIPRO SAFETOUCH SAFETY FISTULA NEEDLE | Nipro Medical Corp. | 2000-11-21 | 74 | 1 |
| K001496 | A.V. FISTULA NEEDLE | Exelint International, Co. | 2000-08-01 | 78 | 0 |
| K000843 | MODIFICATION TO JMS APHERESIS NEEDLE | Jms Co., Ltd. | 2000-04-10 | 26 | 0 |
| K000845 | MODIFICATION TO JMS A.V. FISTULA NEEDLE SET | Jms Co., Ltd. | 2000-04-10 | 26 | 0 |
| K990803 | MEDISYSTEMS BUTTONHOLE NEEDLE SETS | Medisystems Corp. | 2000-01-06 | 302 | 1 |
| K993118 | BIOTEQUE A.V. FISTULA NEEDLE SET | Bioteque Corp. | 1999-12-17 | 88 | 0 |
| K992653 | SHELLY PROTECTED AV FISTULA NEEDLE | Diasol, Inc. | 1999-10-27 | 82 | 0 |
| K990510 | JMS APHERESIS NEEDLE | Jms Co., Ltd. | 1999-08-30 | 193 | 0 |
| K990470 | JMS A. V. FISTULA NEEDLE SET | Jms Co., Ltd. | 1999-08-30 | 195 | 0 |
| K991623 | NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA AR | Nipro Medical Corp. | 1999-08-09 | 90 | 0 |
| K974902 | JMS APHERESIS NEEDLE | Jms Co., Ltd. | 1998-03-30 | 90 | 0 |
| K970962 | JMS AV FISTULA NEEDLE | Jms Co., Ltd. | 1997-08-07 | 143 | 0 |
| K955182 | NIPRO ARTERIAL VENOUS FISTULA NEEDLE | Nissho Corp. | 1996-06-04 | 204 | 0 |
| K945850 | BRAUN DIACAN(R) FISTULA NEEDLES | B. Braun of America, Inc. | 1995-10-06 | 310 | 0 |
| K932074 | MEDISYSTEMS APHERESIS NEEDLE WITH GUARD | Medisystems Corp. | 1994-02-18 | 296 | 0 |
| K915174 | JMS APHERESIS NEEDLE | Jms Co., Ltd. | 1993-03-02 | 473 | 0 |
| K903440 | VIVAMED FISTULA NEEDLE | S.S. Ent. | 1992-04-20 | 629 | 0 |
| K911199 | JMS AV FISTULA NEEDLES | Jms Co., Ltd. | 1991-08-28 | 175 | 0 |
| K910734 | MEDISYSTEMS HEMODIALYSIS FISTULA SET | Medisystems Corp. | 1991-06-20 | 119 | 2 |
| K902564 | NEEDLE, DIALYSIS | Gainor Medical Europe, Ltd. | 1991-03-01 | 263 | 0 |
| K903945 | EXEL A-V FISTULA SET | Exel Intl. | 1990-11-20 | 85 | 0 |
| K900125 | ARTERIOVENOUS FISTULA SETS | Baxter Healthcare Corp | 1990-01-31 | 22 | 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