510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

K-Shield Port Access Infusion Set with High Pressure Tubing

K100720510(k) TraditionalCleared Nov 18, 2010248-day reviewClass II21 CFR 880.5440Recalls 1

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

Kawasumi Laboratories, Inc. · FPA Set, Administration, Intravascular

Cleared on Nov 18, 2010 as substantially equivalent to K060580 (Kawasumi Laboratories, Inc., 2006) and 1 other predicate after a 248-day review. Its family tree reaches back 7 generations to 2000. It has been recalled once.

Decided
Nov 18, 2010
Review
248 days
Class
Class II
Product code
FPA
Recalls
1
Predicates
2

Its longest line of descent runs back 7 generations to K001901 (2000). 21 ancestors in all, the oldest K863606 (1986). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2005: 2 other ancestors2004: 2 other ancestors2001: 1 other ancestor1987: 1 other ancestor2000: 1 other ancestor1986: 1 other ancestor1991: 1 other ancestor1989: 4 other ancestorsK001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalledK012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK050931 · 6 FR DL Powerpicc Catheter · C.R. Bard, Inc. · 2005K051672 · Powerpicc · Bard Access Systems, Inc. · 2005 · recalledK060812 · Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple · C.R. Bard, Inc. · 2006 · recalled198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 3 other ancestors5 generations back: 5 other ancestors K060812 · Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple · C.R. Bard, Inc. · 2006 · recalledK051672 · Powerpicc · Bard Access Systems, Inc. · 2005 · recalledK050931 · 6 FR DL Powerpicc Catheter · C.R. Bard, Inc. · 2005K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalled−50
  1. Root · 7 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 6 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 5 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 4 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
  5. 3 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
  6. 2 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
  7. 1 generation backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
  8. This deviceK100720 K-Shield Port Access Infusion Set with High Pressure TubingKawasumi Laboratories, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−6K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−5K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−4K034019Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc.20041
−3K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc.2005—
−2K051672PowerpiccBard Access Systems, Inc.20051
−1K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.20061
0 (this device)K100720K-Shield Port Access Infusion Set with High Pressure TubingKawasumi Laboratories, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198710
198940
199110
200010
200110
200420
200520
200610
FIG. 1 — Lineage of K100720, 2000–2010Source: 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 FPA? 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 FPA device

  1. #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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? (2)

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
*K060580K-Shield Port Access Infusion Set
Summary page 1
…21 CFR 880.5540. PRODUCT CODE NUMBER: FPA 3. PREDICATE DEVICE: Kawasumi Laboratories Port Access Infusion Set with Antineedle Stick Protector (K(060580), and, Bard Power Loc Safety Infusion Set (K(060812) 4. DESCRIPTION OF THE DEVICE: The K-Shield Port Access Infusion Set with Hi…
Kawasumi Laboratories, Inc.2006—
*K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple
Summary page 2
…material. The technological characteristics of being able to withstand high pressure is substantially equivalent to the Bard device (K0608 12). The other identified differences do not have a significant impact on the safety or effectivenes…
C.R. Bard, Inc.20061

Also cleared against K060580: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 25, 2013Class IIZ-0826-2014Device DesignNavilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 12 months on median.
  • 11 of the 21 ancestors have a recall of any class.
  • 1 other device also cites its predicate K060580.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · FPA

11in 2025

2007: 162008: 182009: 102010: 232011: 122012: 212013: 132014: 222015: 172016: 122017: 172018: 42019: 72020: 102021: 132022: 142023: 142024: 72025: 112026 (partial year): 5
2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007: 75 days median2008: 89 days median2009: 166 days median2010: 120 days median2011: 87 days median2012: 96 days median2013: 90 days median2014: 89 days median2015: 123 days median2016: 195 days median2017: 240 days median2018: 177 days median2019: 161 days median2020: 327 days median2021: 186 days median2022: 213 days median2023: 340 days median2024: 244 days median2025: 225 days median2026 (partial year): 266 days median
2007high 340 (2023) · low 75 (2007)2026

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

Recalls per year · FPA

98in 2025

2007: 172008: 152009: 1662010: 582011: 282012: 16, 4 Class I2013: 642014: 242015: 62016: 102017: 132018: 42019: 132020: 1072021: 12022: 9, 5 Class I2023: 12, 4 Class I2024: 13, 1 Class I2025: 98, 1 Class I2026 (partial year): 10, 2 Class I
2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007: 1,4992008: 1,9412009: 2,5122010: 2,5372011: 4,4072012: 4,9302013: 4,6512014: 4,6952015: 6,6252016: 8,4702017: 6,4622018: 6,5742019: 11,2272020: 9,5632021: 10,4142022: 13,3932023: 10,9162024: 47,2102025: 34,506
2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, 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
20071675171,499
20081889151,941
2009101661662,512
201023120582,537
20111287284,407
2012219616 (4)4,930
20131390644,651
20142289244,695
20151712366,625
201612195108,470
201717240136,462
2018417746,574
201971611311,227
2020103271079,563
202113186110,414
2022142139 (5)13,393
20231434012 (4)10,916
2024724413 (1)47,210
20251122598 (1)34,506
2026526610 (2)—

What is it indicated for?

The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion and blood sampling. The high pressure tubing allows for the injection of contrast media with a power injector to 300 psi into an implanted port indicated for use with a power injector. The device is supplied sterile, non-pyrogenic and for single use.…

Read the full statement (112 words)

The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion and blood sampling. The high pressure tubing allows for the injection of contrast media with a power injector to 300 psi into an implanted port indicated for use with a power injector. The device is supplied sterile, non-pyrogenic and for single use. The port access infusion sets are designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the needle is activated during removal from the patient's implanted medication port.

Indications for use as stated in the FDA summary.

Also cleared against K060580

1 other device cites the same predicate.

  • K123344K-Shield Advantage Port Access Infusion Set (Pais)Kawasumi Laboratories, Inc. · 2013

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
  • K102994K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2010

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The FPA category page

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https://510kreport.com/device/K100720 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100720: K-Shield Port Access Infusion Set with High Pressure Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100720

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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