510(k) Report

510(k) · Cleared

Cleared

Extension Set with BD Q-Syte Luer Access Split Septum

K142527510(k) TraditionalCleared Sep 19, 201411-day reviewClass II21 CFR 880.5440

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

Acacia, Inc. · FPA Set, Administration, Intravascular

Cleared on Sep 19, 2014 as substantially equivalent to K090809 (Mps Acacia, 2009) and 2 other predicates after an 11-day review. Its family tree reaches back 10 generations to 2000. 1 later device descends from it.

Decided
Sep 19, 2014
Review
11 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
3

Its longest line of descent runs back 10 generations to K001901 (2000). 43 ancestors in all, the oldest K863606 (1986). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 4 other ancestors1989: 5 other ancestors2008: 1 other ancestor2003: 1 other ancestor1997: 1 other ancestor2007: 1 other ancestor2004: 3 other ancestors2000: 1 other ancestor1998: 1 other ancestor2006: 1 other ancestor2005: 2 other ancestors2001: 2 other ancestors1996: 1 other ancestor1994: 3 other ancestors1992: 1 other ancestor1991: 1 other ancestor1988: 1 other ancestor1987: 2 other ancestors1986: 1 other ancestor2021: 1 descendant clearedK001901 · 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 · recalledK062414 · Vortex CT Port Access System and Lifeguard Safety Infusion Set · Rita Medical Systems, Inc. · 2007 · recalledK073050 · Safestep Max Power-Injectable Infusion Set · Specialized Health Products International, Inc. · 2008 · recalledK090809 · MPS Acacia Power Injectable Infusion Set · Mps Acacia · 20091990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 6 other ancestors4 generations back: 17 other ancestors5 generations back: 3 other ancestors6 generations back: 2 other ancestors 1 generation forward: 1 descendant K090809 · MPS Acacia Power Injectable Infusion Set · Mps Acacia · 2009K073050 · Safestep Max Power-Injectable Infusion Set · Specialized Health Products International, Inc. · 2008 · recalledK062414 · Vortex CT Port Access System and Lifeguard Safety Infusion Set · Rita Medical Systems, Inc. · 2007 · recalledK060812 · 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−10−50
  1. Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 6 generations between
  3. 3 generations backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
  4. 2 generations backK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
  5. 1 generation backK090809 MPS Acacia Power Injectable Infusion SetMps Acacia · 2009
  6. This deviceK142527 Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc. · 2014
  7. Descendant · cites it directly · 0 of its ownK202672 Precision Delivery Infusion SetQuest Medical, Inc. · 2021 · Recalled
Show all 10 generations
  1. Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 9 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 8 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 7 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
  5. 6 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
  6. 5 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
  7. 4 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
  8. 3 generations backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
  9. 2 generations backK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
  10. 1 generation backK090809 MPS Acacia Power Injectable Infusion SetMps Acacia · 2009
  11. This deviceK142527 Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc. · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K202672Precision Delivery Infusion SetQuest Medical, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−9K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−8K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−7K034019Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc.20041
−6K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc.2005—
−5K051672PowerpiccBard Access Systems, Inc.20051
−4K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.20061
−3K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc.20072
−2K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.20082
−1K090809MPS Acacia Power Injectable Infusion SetMps Acacia2009—
0 (this device)K142527Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc.2014—
+1K202672Precision Delivery Infusion SetQuest Medical, Inc.20211

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198720
198810
198950
199110
199210
199430
199610
199710
199810
200010
200120
200240
200310
200430
200520
200610
200710
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
FIG. 1 — Lineage of K142527, 2000–2021Source: 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? (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
*K090809MPS Acacia Power Injectable Infusion Set
Summary page 5
…CLASSIFICATION NAME: Intravascular Administration Set DEVICE CLASSIFICATION: Class Il ProbucTt CODE FPA PREDICATE DEVICES: MPS Acacia Power Injectable Infusion Set (K090809) MPS Acacia IV Extension Sets (K895367) BD Q-Syte Saf-T PRN Luer Activated Valve (K013621) Substantially Equivalent To: The sub…
Mps Acacia2009—
*K895367Intravenous Extension Set
Summary page 5
…ministration Set DEVICE CLASSIFICATION: Class Il ProbucTt CODE FPA PREDICATE DEVICES: MPS Acacia Power Injectable Infusion Set (K090809) MPS Acacia IV Extension Sets (K895367) BD Q-Syte Saf-T PRN Luer Activated Valve (K013621) Substantially Equivalent To: The subject Extension Sets with BD Q-Syte™ Lue…
Medical Product Specialists19896
*K013621BD Saf-T PRN Luer Activated Valve, Model 385100
Summary page 5
…ProbucTt CODE FPA PREDICATE DEVICES: MPS Acacia Power Injectable Infusion Set (K090809) MPS Acacia IV Extension Sets (K895367) BD Q-Syte Saf-T PRN Luer Activated Valve (K013621) Substantially Equivalent To: The subject Extension Sets with BD Q-Syte™ Luer Access Split Septum are substantially equivalent…
Becton Dickinson Infusion Therapy Systems, Inc.200211

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K202672Precision Delivery Infusion SetQuest Medical, Inc.20210

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 14 years and passes through 6 companies; a new generation was cleared every 12 months on median.
  • 25 of the 43 ancestors have a recall of any class.
  • Of its descendants, K202672 (Quest Medical, Inc., 2021) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?

Non-Power Injectable: Extension Sets with an attached BD Q-Syte™ Luer Access Split Septum are intended to be used with intravascular catheters to aspirate blood or administer fluids, including medications and blood or blood products. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused. Power Injectable: The Power Injectable Extension Set with an attached BD Q-Syte™ Luer…

Read the full statement (168 words)

Non-Power Injectable:

Extension Sets with an attached BD Q-Syte™ Luer Access Split Septum are intended to be used with intravascular catheters to aspirate blood or administer fluids, including medications and blood or blood products. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.

Power Injectable:

The Power Injectable Extension Set with an attached BD Q-Syte™ Luer Access Split Septum is intended to be used with intravascular catheters to aspirate blood or administer fluids, including medications and blood or blood products. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.

The Power Injectable Extension Set is also indicated for use with intravascular catheters indicated for power injection of contrast media. The Power Injectable Extension Set is suitable for use with power injectors set to a maximum pressure of 325 psi (2,240 kPa) when the BD Q-Syte device is removed and a direct connection is made.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Acacia, Inc.

17 FDA decisions under this applicant name. See the company

  • K122449Enteral Nutrition WarmerAcacia, Inc. · 2013
  • K111381Medi-Sis Syringe Infusion SystemAcacia, Inc. · 2012
  • K103165Blood Sampling SetAcacia, Inc. · 2010
  • K092986Acacia Piston SyringeAcacia, Inc. · 20091 recall
  • K972538Flow-Eze Blunt Cannula (1999BC)Acacia, Inc. · 1998

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https://510kreport.com/device/K142527 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142527: Extension Set with BD Q-Syte Luer Access Split Septum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142527

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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