510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Radiation Sterilized Admin. Set

K811078510(k) TraditionalCleared Jul 2, 198173-day reviewClass II21 CFR 880.5440Recalls 17

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

Travenol Laboratories, S.A. · FPA Set, Administration, Intravascular

Cleared on Jul 2, 1981 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 17 times.

Decided
Jul 2, 1981
Review
73 days
Class
Class II
Product code
FPA
Recalls
17
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2014: 2 descendants cleared2012: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared19801990200020102020
  1. This deviceK811078 Radiation Sterilized Admin. SetTravenol Laboratories, S.A. · 1981
  2. Descendant · cites it directly · 3 of its ownK073339 Blood Component Recipient Set with Standard Size Filter and Infusion…Fenwal, Inc. · 2008
  3. Descendant · 2 generations on · 2 of its ownK111702 Amicus Separator System- Use in Therapeutic Plasma Exchange and…Fenwal, Inc. · 2012 · Recalled
  4. Descendant · cites it directly · 1 of its ownK142011 Solution Set/Extension SetBaxter Healthcare Corporation · 2014
  5. Descendant · 3 generations on · 1 of its ownK141019 Amicus Separator System/ Amicus Seperator System;RefurbishedFenwal, Inc. · 2014
  6. Descendant · 4 generations on · 0 of its ownK162462 AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc · 2016

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008: 12012: 12014: 22015: 12016: 1
2008high 2 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K073339Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm…Fenwal, Inc. · 2008 · cites it directly3descendants
  • K111702Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus TpeFenwal, Inc. · 2012 · 2 generations on2descendants
  • K142011Solution Set/Extension SetBaxter Healthcare Corporation · 2014 · cites it directly1descendant
  • K141019Amicus Separator System/ Amicus Seperator System;RefurbishedFenwal, Inc. · 2014 · 3 generations on1descendant
  • K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc · 2016 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K811078Radiation Sterilized Admin. SetTravenol Laboratories, S.A.1981—
+1K073339Blood Component Recipient Set with Standard Size Filter and Infusion Set with…Fenwal, Inc.2008—
+2K111702Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for…Fenwal, Inc.20121
+1K142011Solution Set/Extension SetBaxter Healthcare Corporation2014—
+3K141019Amicus Separator System/ Amicus Seperator System;RefurbishedFenwal, Inc.2014—
+4K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201210
201420
201510
201610
FIG. 1 — Lineage of K811078, 1981–2016Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073339Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm…Fenwal, Inc.20083
K142011Solution Set/Extension SetBaxter Healthcare Corporation20141

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 28, 2013Class IIZ-1268-2013Packaging process controlCustomers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Sep 9, 2010Not classifiedZ-0149-2011Package design/selectionDuring packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch.
Dec 15, 2005Not classifiedZ-0639-06OtherThe extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Dec 15, 2005Not classifiedZ-0635-06OtherThe extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Dec 15, 2005Not classifiedZ-0645-06OtherThe extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Dec 15, 2005Not classifiedZ-0649-06OtherThe extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Dec 15, 2005Not classifiedZ-0627-06OtherThe extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Dec 15, 2005Not classifiedZ-0628-06OtherThe extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Dec 15, 2005Not classifiedZ-0646-06OtherThe extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Jul 6, 2005Not classifiedZ-1101-05OtherLeaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.
Oct 17, 2002Not classifiedZ-0506-03OtherThe I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Oct 17, 2002Not classifiedZ-0511-03OtherThe I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Oct 17, 2002Not classifiedZ-0514-03OtherThe I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Oct 17, 2002Not classifiedZ-0515-03OtherThe I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Oct 17, 2002Not classifiedZ-0516-03OtherThe I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Oct 17, 2002Not classifiedZ-0513-03OtherThe I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Oct 17, 2002Not classifiedZ-0512-03OtherThe I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

The 5 latest of 17 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K073339 (Fenwal, Inc., 2008) has gone furthest, with 3 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)—

More from Travenol Laboratories, S.A.

206 FDA decisions under this applicant name. See the company

  • K874181Baxter Bedside SystemTravenol Laboratories, S.A. · 1988
  • K873894Continu-Flo Solution W/Check Valve 2 Y-Inject SiteTravenol Laboratories, S.A. · 1987
  • K873873Resubmitted Micron Transfusion FilterTravenol Laboratories, S.A. · 1987
  • K873984Automatic Peritoneal Dialysis Cycler Set (5C4437)Travenol Laboratories, S.A. · 1987
  • K872364Hemodialysis (SPS), Model 550, Code 5M1309Travenol Laboratories, S.A. · 19872 recalls

Recent decisions in FPA

The FPA category page

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https://510kreport.com/device/K811078 · printed Nov 6, 2026

Cite this page

510(k) Report. “K811078: Radiation Sterilized Admin. Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811078

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026