510(k) Report

510(k) · Cleared

Cleared

JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle Set

K030479510(k) TraditionalCleared Aug 18, 2003186-day reviewClass II21 CFR 880.5200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Jms North America Corp. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Aug 18, 2003 after a 186-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.

Decided
Aug 18, 2003
Review
186 days
Class
Class II
Product code
FOZ
Recalls
None
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2007: 1 descendant cleared2011: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK030479 JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle SetJms North America Corp. · 2003
  2. Descendant · cites it directly · 7 of its ownK051814 JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle SetJms North America Corp. · 2005
  3. Descendant · 2 generations on · 6 of its ownK070234 JMS Sysloc Mini Avf and Apheresis Needle SetsJms North America Corp. · 2007
  4. Descendant · 3 generations on · 2 of its ownK110157 Sysloc Mini V3JMS North America Corporation · 2011
  5. Descendant · 3 generations on · 2 of its ownK082882 A.V. Fistula Blunt Needle SetJms North America Corp. · 2009
  6. Descendant · 4 generations on · 1 of its ownK142564 JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI…JMS North America Corporation · 2014

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12009: 12010: 12011: 12014: 12015: 12026: 1
2005high 1 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 8 · See all
  • K051814JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle SetJms North America Corp. · 2005 · cites it directly7descendants
  • K070234JMS Sysloc Mini Avf and Apheresis Needle SetsJms North America Corp. · 2007 · 2 generations on6descendants
  • K110157Sysloc Mini V3JMS North America Corporation · 2011 · 3 generations on2descendants
  • K082882A.V. Fistula Blunt Needle SetJms North America Corp. · 2009 · 3 generations on2descendants
  • K142564JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)JMS North America Corporation · 2014 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030479JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle SetJms North America Corp.2003—
+1K051814JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle SetJms North America Corp.2005—
+2K070234JMS Sysloc Mini Avf and Apheresis Needle SetsJms North America Corp.2007—
+3K110157Sysloc Mini V3JMS North America Corporation2011—
+3K082882A.V. Fistula Blunt Needle SetJms North America Corp.2009—
+4K142564JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle…JMS North America Corporation2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200910
201010
201110
201410
201510
202610
FIG. 1 — Lineage of K030479, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FOZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FOZ device

  1. #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051814JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle SetJms North America Corp.20057

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K051814 (Jms North America Corp., 2005) has gone furthest, with 7 descendants of its own.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FOZ

11in 2025

2007: 62008: 92009: 92010: 32011: 62012: 132013: 42014: 92015: 102016: 92017: 92018: 12019: 82020: 102021: 42022: 82023: 92024: 62025: 112026 (partial year): 7
2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007: 159 days median2008: 103 days median2009: 30 days median2010: 28 days median2011: 132 days median2012: 122 days median2013: 104 days median2014: 99 days median2015: 107 days median2016: 63 days median2017: 51 days median2019: 140 days median2020: 191 days median2021: 242 days median2022: 183 days median2023: 129 days median2024: 190 days median2025: 91 days median2026 (partial year): 203 days median
2007high 242 (2021) · low 28 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FOZ

4in 2023

2007: 162009: 232010: 1152013: 22014: 42016: 3, 1 Class I2017: 222018: 42019: 32020: 32021: 12022: 4, 2 Class I2023: 4, 2 Class I2026 (partial year): 2
2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007: 3742008: 4222009: 5082010: 3702011: 7862012: 5602013: 6402014: 8152015: 7292016: 9252017: 1,9662018: 3,3052019: 4,3652020: 3,7972021: 4,6742022: 4,1332023: 4,4302024: 4,7722025: 5,110
2007high 5,110 (2025) · low 370 (2010)2025

MAUDE reports naming product code FOZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007615916374
200891030422
200993023508
2010328115370
201161320786
2012131220560
201341042640
20149994815
2015101070729
20169633 (1)925
2017951221,966
20181—43,305
2019814034,365
20201019133,797
2021424214,674
202281834 (2)4,133
202391294 (2)4,430
2024619004,772
2025119105,110
202672032—

What is it indicated for?

Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The device has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries when withdrawing and discarding the needle after treatment.

Indications for use as stated in the FDA 510(k) statement.

More from Jms North America Corp.

10 FDA decisions under this applicant name. See the company

  • K093637JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300 and 820-7300Jms North America Corp. · 2010
  • K082882A.V. Fistula Blunt Needle SetJms North America Corp. · 2009
  • K070234JMS Sysloc Mini Avf and Apheresis Needle SetsJms North America Corp. · 2007
  • K070143JMS Planecta StopcockJms North America Corp. · 2007
  • K051814JMS Sysloc Mini a.V. Fistula Needle Set and Apheresis Needle SetJms North America Corp. · 2005

Recent decisions in FOZ

The FOZ category page

  • K260432Ruby Intravascular CatheterVenocare, Inc. · 2026
  • K260165Unimpregnated Central Venous CatheterSpectrum Vascular · 2026
  • K261041ClearSafe Closed SystemMedSource Labs, LLC · 2026
  • K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC · 2026
  • K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc. · 2026

https://510kreport.com/device/K030479 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030479: JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030479

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026