510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Intravascular Administration Set

K993463510(k) TraditionalCleared Jan 4, 200083-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

Custom Assemblies, Inc. · FPA Set, Administration, Intravascular

Cleared on Jan 4, 2000 as substantially equivalent to K940319 (R-Group Intl., 1994) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1994. It has been recalled once.

Decided
Jan 4, 2000
Review
83 days
Class
Class II
Product code
FPA
Recalls
1
Predicates
2

Its longest line of descent runs back 1 generation to K940319 (1994). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestorK940319 · R-Group International Coiled Low Pressure Extension Line · R-Group Intl. · 19941990199219941996199820002002
Other ancestors, by generation 1 generation back: 1 other ancestor K940319 · R-Group International Coiled Low Pressure Extension Line · R-Group Intl. · 19940
  1. Root · 1 generation backK940319 R-Group International Coiled Low Pressure Extension LineR-Group Intl. · 1994
  2. This deviceK993463 Intravascular Administration SetCustom Assemblies, Inc. · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K940319R-Group International Coiled Low Pressure Extension LineR-Group Intl.1994—
0 (this device)K993463Intravascular Administration SetCustom Assemblies, Inc.2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K993463, 1994–2000Source: 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
*K940319R-Group International Coiled Low Pressure Extension Line
Summary page 1
…ension set Common/Usual Name: Intravascular Administration Set Classification Name: Intravascular Administration Set Device: Extension set Predicate Devices: R-Group - K940319 The Kipp Group - I.V. Administration Set - K991932 The Custom Assemblies Extension Set is a tubing set with various connectors,…
R-Group Intl.1994—
*K991932Intravascular Administration Set
Summary page 1
…tration Set Classification Name: Intravascular Administration Set Device: Extension set Predicate Devices: R-Group - K940319 The Kipp Group - I.V. Administration Set - K991932 The Custom Assemblies Extension Set is a tubing set with various connectors, and accessories, such as drip chambers, infusion li…
The Kipp Group19992

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
Oct 28, 2021Class IIZ-0400-2022Employee errorThis recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.

How does its category compare?

All FPA devices

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

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?

Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration.

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

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/K993463 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993463: Intravascular Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993463

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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