510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

IV Administration and Connect Sets

K033301510(k) TraditionalCleared Mar 4, 2004142-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

Codan US Corp. · FPA Set, Administration, Intravascular

Cleared on Mar 4, 2004 after a 142-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it. It has been recalled once.

Decided
Mar 4, 2004
Review
142 days
Class
Class II
Product code
FPA
Recalls
1
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2024: 2 descendants cleared2022: 1 descendant cleared2025: 2 descendants cleared200020052010201520202025
  1. This deviceK033301 IV Administration and Connect SetsCodan US Corp. · 2004
  2. Descendant · cites it directly · 5 of its ownK112314 Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220…Nephros, Inc. · 2012
  3. Descendant · 2 generations on · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
  4. Descendant · 3 generations on · 1 of its ownK243505 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
  5. Descendant · 2 generations on · 1 of its ownK210575 HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros · 2022
  6. Descendant · 4 generations on · 0 of its ownK251851 DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012: 12022: 12024: 22025: 2
2012high 2 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · See all
  • K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc. · 2012 · cites it directly5descendants
  • K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · 2 generations on2descendants
  • K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · 3 generations on1descendant
  • K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros · 2022 · 2 generations on1descendant
  • K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K033301IV Administration and Connect SetsCodan US Corp.2004—
+1K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc.2012—
+2K2315345008X Hemodialysis SystemFresenius Medical Care20241
+3K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC20256
+2K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros2022—
+4K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
202210
202420
202520
FIG. 1 — Lineage of K033301, 2004–2025Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc.20125

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 12, 2019Class IIZ-2433-2020Packaging process controlIndividual packages of connectors may have incomplete or bad seals which would compromise sterility.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K112314 (Nephros, Inc., 2012) has gone furthest, with 5 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.

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 CODAN IVAdministration sets, In-line sets and Connect Sets are indicated for use 1.o facilitate the continuous and bolus infusion of IVfluids, pain control medications, chemotherapeutic drugs and pharmaceuticals into patient vascular systems.

Indications for use as stated in the FDA 510(k) statement.

More from Codan US Corp.

7 FDA decisions under this applicant name. See the company

  • K112268Codan Safefeed Enteral Feeding ReservoirCodan US Corp. · 2012
  • K042693IV Administration Set B400 SPCodan US Corp. · 2004
  • K021480Extension Set Light-Safe, Model BC565Codan US Corp. · 2002
  • K013714Codan US I.V. Administration Set, Model B400 SPCodan US Corp. · 2002
  • K001872I.V. Set-Luer Lock with Latex Free Injection Site, Model B411Codan US Corp. · 2000

Recent decisions in FPA

The FPA category page

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  • 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
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https://510kreport.com/device/K033301 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033301: IV Administration and Connect Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033301

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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