510(k) Report

510(k) · Cleared

Cleared

Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration Set ( Standard

K093271510(k) TraditionalCleared Jan 27, 2010100-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

Victus, Inc. · FPA Set, Administration, Intravascular

Cleared on Jan 27, 2010 as substantially equivalent to K023469 (Victus, Inc., 2002) and 13 other predicates after a 100-day review. Its family tree reaches back 2 generations to 1992. 1 of the 19 devices in its family, counting itself, has a Class I recall.

Decided
Jan 27, 2010
Review
100 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
14

Its longest line of descent runs back 2 generations to K921860 (1992). 18 ancestors in all, the oldest K884370 (1988). No later device cites it as a predicate yet. 1 of the 19 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2005: 1 other ancestor2003: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor1997: 3 other ancestors, 1 with a Class I recall11995: 2 other ancestors1994: 1 other ancestor1990: 1 other ancestor1989: 2 other ancestors1988: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestorReference device: K832952 · Millipore Ivex Int Filter Unit · Millipore Corp. · 1983Reference device: K061115 · Speedflow 0.2UM Filter, Model 11214; Speedflow 1.2UM Filter, Model 11215; Easydrop Controller, Model 11216 · Gvs Spa · 2006Reference device: K002689 · Swabsite Swabbable Valve, Model 245000 · Quest Medical, Inc. · 2001K921860 · Modification to IV Spike · Mcgaw, Inc. · 1992 · recalledK023469 · Victus I.V. Administration Set, Models 27058, 27059,27062 · Victus, Inc. · 2002198519901995200020052010
Other ancestors, by generation 1 generation back: 13 other ancestors, 1 with a Class I recall12 generations back: 3 other ancestors K023469 · Victus I.V. Administration Set, Models 27058, 27059,27062 · Victus, Inc. · 2002K921860 · Modification to IV Spike · Mcgaw, Inc. · 1992 · recalled0
  1. Root · 2 generations backK921860 Modification to IV SpikeMcgaw, Inc. · 1992 · Recalled
  2. 1 generation backK023469 Victus I.V. Administration Set, Models 27058, 27059,27062Victus, Inc. · 2002
  3. This deviceK093271 Extension Set (Standardbore Tubing), Extension Set (Minibore…Victus, Inc. · 2010

Class I recalls in this family

  • K964435 Primary IV Setdirect predicate · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K921860Modification to IV SpikeMcgaw, Inc.19926
−1K023469Victus I.V. Administration Set, Models 27058, 27059,27062Victus, Inc.2002—
0 (this device)K093271Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV…Victus, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
198920
199010
199110
199210
199410
199520
199731
200110
200210
200310
200510
FIG. 1 — Lineage of K093271, 1992–2010Source: 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.

1 device in this family has a Class I recall. 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? (14)

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
*K023469Victus I.V. Administration Set, Models 27058, 27059,27062
Summary page 1
…21 C.F.R §880.5440 Intravascular Administration Set ProCode 80 FPA PredicateVictus WV Administration Sets (K023469; K030246) Nilces ~Millipore/NP Medical IVEX Filter (K832952)* GVS SPA Flow Regulator (K061 115)*…
Victus, Inc.2002—
*K030246Victus I.V. Administration Set, Models 27071 and 27072
Summary page 1
…21 C.F.R §880.5440 Intravascular Administration Set ProCode 80 FPA PredicateVictus WV Administration Sets (K023469; K030246) Nilces ~Millipore/NP Medical IVEX Filter (K832952)* GVS SPA Flow Regulator (K061 115)* Halk…
Victus, Inc.2003—
*K952810Dosi-Flow, Models 20 & 30
Summary page 1
…Leventon S.A. Administration Set and Extension Set with Flow Regulator with and without "Y" Connector or Needleless Access Connector (K9528 10) Churchill Medical Systems Extension Set with 0.22p & l.2p filter (K884370), (K894954), and…
Leventon, S.A.1995—
*K884370CMS IV Extension Sets
Summary page 1
…with and without "Y" Connector or Needleless Access Connector (K9528 10) Churchill Medical Systems Extension Set with 0.22p & l.2p filter (K884370), (K894954), and (K02 1395), and Administration Set (K896333) and (KOI11336)…
Churchill Medical Systems, Inc.1988—
*K894954.22 & 1.2 Micron IV Filters
Summary page 1
…"Y" Connector or Needleless Access Connector (K9528 10) Churchill Medical Systems Extension Set with 0.22p & l.2p filter (K884370), (K894954), and (K02 1395), and Administration Set (K896333) and (KOI11336) ICU Medical, Inc. Administ…
Churchill Medical Systems, Inc.1989—
*K021395Modification to 30 Extension Set
Summary page 1
…r Needleless Access Connector (K9528 10) Churchill Medical Systems Extension Set with 0.22p & l.2p filter (K884370), (K894954), and (K02 1395), and Administration Set (K896333) and (KOI11336) ICU Medical, Inc. Administration Set and E…
Churchill Medical Systems, Inc.200218
*K896333CMS IV Filters
Summary page 1
…8 10) Churchill Medical Systems Extension Set with 0.22p & l.2p filter (K884370), (K894954), and (K02 1395), and Administration Set (K896333) and (KOI11336) ICU Medical, Inc. Administration Set and Extension Set with Needle-Free…
Churchill Medical Systems, Inc.1990—
*K011336Primary Solution Set with Universal Spike, Injection Site and Male Luer LockChurchill Medical Systems, Inc.20019
*K964435Primary IV Set
Summary page 1
…KOI11336) ICU Medical, Inc. Administration Set and Extension Set with Needle-Free straight connector and Needle-Free Injection Site (K964435) and (K970855) Hospira, Inc. Microbore Extension Set (K052722) McGAW, Inc. (B.Braun Medical…
Icu Medical, Inc.1997Class I
*K970855Clave Connector
Summary page 1
…ICU Medical, Inc. Administration Set and Extension Set with Needle-Free straight connector and Needle-Free Injection Site (K964435) and (K970855) Hospira, Inc. Microbore Extension Set (K052722) McGAW, Inc. (B.Braun Medical) Administrati…
Icu Medical, Inc.199752
*K052722Lifeshield Latex-Free Microbore Extension Set, Model 14949 and Others
Summary page 1
…et with Needle-Free straight connector and Needle-Free Injection Site (K964435) and (K970855) Hospira, Inc. Microbore Extension Set (K052722) McGAW, Inc. (B.Braun Medical) Administration Set (K932165) Kendall McGAW Laboratories, Inc…
Hospira, Inc.20051
*K932165Intravascular Administration Set
Summary page 1
…tion Site (K964435) and (K970855) Hospira, Inc. Microbore Extension Set (K052722) McGAW, Inc. (B.Braun Medical) Administration Set (K932165) Kendall McGAW Laboratories, Inc. Administration Set with l.2p filter (K896292)…
Mcgaw, Inc.1994—
*K8962921.2 Micron Filter with IV Set
Summary page 1
…McGAW, Inc. (B.Braun Medical) Administration Set (K932165) Kendall McGAW Laboratories, Inc. Administration Set with l.2p filter (K896292) AMSINO INTL., INC. Administration Set with Flow regulator (K973 107) *Note: Components…
Kendall Mcgaw Laboratories, Inc.1989—
*K973107Amsino I.V. Administration Set
Summary page 1
…all McGAW Laboratories, Inc. Administration Set with l.2p filter (K896292) AMSINO INTL., INC. Administration Set with Flow regulator (K973 107) *Note: Components manufactured by these companies will be used in the manufacture…
Amsino Intl., Inc.1997—
†K832952Millipore Ivex Int Filter UnitMillipore Corp.1983—
†K061115Speedflow 0.2UM Filter, Model 11214; Speedflow 1.2UM Filter, Model 11215; Easydrop…Gvs Spa2006—
†K002689Swabsite Swabbable Valve, Model 245000Quest Medical, Inc.2001—

Also cleared against K023469: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K964435Primary IV SetIcu Medical, Inc. · 1997 · Direct predicate · ◆ in the 1997 ancestors bar of FIG. 15 Class I recalls

What does this lineage say?

  • The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 10.4 years on median.
  • 9 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
  • 1 other device also cites its predicate K023469.

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?

To administer IV fluids/medication to a patient's vascular system.

Indications for use as stated in the FDA summary.

Also cleared against K023469

1 other device cites the same predicate.

  • K041495Pentadeflue IV Solution Administration SetsPentaferte S.P.A · 2005

More from Victus, Inc.

3 FDA decisions under this applicant name. See the company

  • K030246Victus I.V. Administration Set, Models 27071 and 27072Victus, Inc. · 2003
  • K023469Victus I.V. Administration Set, Models 27058, 27059,27062Victus, Inc. · 2002

Recent decisions in FPA

The FPA category page

  • K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
  • K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
  • K261530iiSure Infusion SetDeka Research and Development · 2026
  • K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF…Amsino International, Inc. · 2026
  • K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026

https://510kreport.com/device/K093271 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093271: Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration Set ( Standard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093271

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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