510(k) Report

510(k) · Cleared

Cleared

K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector

K102994510(k) SpecialCleared Nov 3, 201026-day reviewClass II21 CFR 880.5570

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

Kawasumi Laboratories, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Nov 3, 2010 as substantially equivalent to K073257 (Kawasumi Laboratories, Inc., 2008) and 2 other predicates after a 26-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.

Decided
Nov 3, 2010
Review
26 days
Class
Class II
Product code
FMI
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K970259 (1997). 7 ancestors in all, the oldest K873421 (1987). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor1994: 1 other ancestor2000: 2 other ancestors1987: 1 other ancestor2018: 1 descendant clearedK970259 · E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set · Becton Dickinson Vascular Access, Inc. · 1997K980414 · Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors 1 generation forward: 1 descendant K980414 · Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · recalledK970259 · E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set · Becton Dickinson Vascular Access, Inc. · 19970
  1. Root · 2 generations backK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
  2. 1 generation backK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
  3. This deviceK102994 K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2010
  4. Descendant · cites it directly · 0 of its ownK172957 Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K970259E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc.1997—
−1K980414Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer…Bd Becton Dickinson Vacutainer Systems Preanalytic19981
0 (this device)K102994K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc.2010—
+1K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199410
200020
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K102994, 1997–2018Source: 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 summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMI? 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 FMI device

  1. #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K073257Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector
Summary page 1
…lass 1I, Codified at 21 CFR 880.5570. PRODUCT CODE NUMBER: PFM1 3. PREDICATE DEVICE: Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector (K073257), Medisystems Masterguard (K(932074) and the Becton Dickinson Vacutainer Brand Safety-Lok Blood Collection Set (K980414 )…
Kawasumi Laboratories, Inc.2008—
*K932074Medisystems Apheresis Needle with Guard
Summary page 2
…tified predicate devices and performs as well as the predicate devices Large Wing Sets with Antineedle Stick Protector (073257), Medisystems Masterguard (K932074) and the Becton Dickinson Vacutainer Safety- Lok Blood Collection Set (980414) for their intended use. DE…
Medisystems Corp.1994—
*K980414Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood…
Summary page 1
…with Antineedle Stick Protector (K073257), Medisystems Masterguard (K(932074) and the Becton Dickinson Vacutainer Brand Safety-Lok Blood Collection Set (K980414 ). 4. DESCRIPTION OF THE DEVICE: The K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector, K-Shield Bl…
Bd Becton Dickinson Vacutainer Systems Preanalytic19981

Also cleared against K073257: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc.20180

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?

  • The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 12.7 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K172957 (Kawasumi Laboratories, Inc., 2018) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K073257.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · FMI

11in 2025

2007: 152008: 102009: 72010: 152011: 122012: 172013: 112014: 142015: 102016: 202017: 92018: 202019: 122020: 112021: 182022: 232023: 182024: 32025: 112026 (partial year): 12
2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007: 71 days median2008: 85 days median2009: 177 days median2010: 119 days median2011: 113 days median2012: 107 days median2013: 87 days median2014: 155 days median2015: 89 days median2016: 217 days median2017: 253 days median2018: 176 days median2019: 186 days median2020: 263 days median2021: 143 days median2022: 189 days median2023: 112 days median2024: 90 days median2025: 141 days median2026 (partial year): 119 days median
2007high 263 (2020) · low 71 (2007)2026

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

Recalls per year · FMI

1in 2024

2007: 22008: 42009: 32010: 792011: 52012: 12013: 12014: 32015: 12017: 162019: 52020: 32021: 72023: 22024: 12026 (partial year): 1, 1 Class I
2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007: 2082008: 1772009: 2632010: 2492011: 2402012: 2152013: 2552014: 2872015: 5672016: 9412017: 1,5472018: 2,3982019: 4,8962020: 4,2452021: 4,5322022: 4,8852023: 4,9862024: 4,0532025: 2,424
2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, 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
200715712208
200810854177
200971773263
20101511979249
2011121135240
2012171071215
201311871255
2014141553287
201510891567
2016202170941
20179253161,547
20182017602,398
20191218654,896
20201126334,245
20211814374,532
20222318904,885
20231811224,986
202439014,053
20251114102,424
2026121191 (1)—

What is it indicated for?

Name: Kawasumni A.V. Fistula Set Intended Use: This device is intended to be used to access a vein or artery and to be used as a conduit to connect to blood tubing lines for performing patient hemodialysis. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein or artery. Name: Kawasumni…

Read the full statement (228 words)

Name: Kawasumni A.V. Fistula Set

Intended Use: This device is intended to be used to access a vein or artery and to be used as a conduit to connect to blood tubing lines for performing patient hemodialysis. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein or artery.

Name: Kawasumni Laboratory Blood Drawing Kit

Intended Use: This is a therapeutic device used to access a patients vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. This device is not intended for blood transfusions. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein.

Name: Kawasumi Laboratories Phlebotomy Set

Intended Use: This device is intended to be used to access a patient's vein and as a conduit for blood removal to a vacuum bottle to aid in the treatment of a disease or other condition. The device is designddi with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein.

Indications for use as stated in the FDA summary.

Also cleared against K073257

1 other device cites the same predicate.

  • K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc. · 2018

More from Kawasumi Laboratories, Inc.

11 FDA decisions under this applicant name. See the company

  • K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)Kawasumi Laboratories, Inc. · 2019
  • K190233K-Shield Advantage Port Access Infusion Set (PAIS)Kawasumi Laboratories, Inc. · 2019
  • K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc. · 2018
  • K123344K-Shield Advantage Port Access Infusion Set (Pais)Kawasumi Laboratories, Inc. · 2013
  • K100720K-Shield Port Access Infusion Set with High Pressure TubingKawasumi Laboratories, Inc. · 20101 recall

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https://510kreport.com/device/K102994 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102994: K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102994

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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