510(k) Report

510(k) · Cleared

Recalled · 2009

Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure

K033576510(k) SpecialCleared Dec 4, 200321-day reviewClass II21 CFR 880.5440Recalls 6

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

Abbott Laboratories · FPA Set, Administration, Intravascular

Cleared on Dec 4, 2003 as substantially equivalent to K971293 (Abbott Mfg., Inc., 1997) and 5 other predicates after a 21-day review. Its family tree reaches back 1 generation to 1979. It has been recalled 6 times.

Decided
Dec 4, 2003
Review
21 days
Class
Class II
Product code
FPA
Recalls
6
Predicates
6

Its longest line of descent runs back 1 generation to K790062 (1979). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1994: 1 other ancestor1992: 1 other ancestor1988: 1 other ancestor1983: 1 other ancestorK790062 · IV Administration Set with Backcheck · National Patent Development Corp. · 1979 · recalled1975198019851990199520002005
Other ancestors, by generation 1 generation back: 5 other ancestors K790062 · IV Administration Set with Backcheck · National Patent Development Corp. · 1979 · recalled0
  1. Root · 1 generation backK790062 IV Administration Set with BackcheckNational Patent Development Corp. · 1979 · Recalled
  2. This deviceK033576 Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient…Abbott Laboratories · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K790062IV Administration Set with BackcheckNational Patent Development Corp.197961
0 (this device)K033576Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line…Abbott Laboratories2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198810
199210
199410
199710
FIG. 1 — Lineage of K033576, 1979–2003Source: 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? (6)

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
*K971293Lifeshield Primary I.V. Set with Backcheck Valve
Summary page 3
…12/12/91 09/21/92 K944125 Abbott LTE Infusion Pump & IV Sets 08/16/94 12/06/94 K971293 Lifeshield Primary IV Set with Backcheck Valve 04/04/97 06/27/97 12. Comparison to Legally Market…
Abbott Mfg., Inc.19971
*K790062IV Administration Set with Backcheck
Summary page 2
…. The current set has a total tubing length of 110 inches (nominal). 3) The PAV's in the modified set contain a comparable silicone material cleared under K790062 (IV Administration Set with Backcheck), and are currently manufactured and sold by B. Braun Medical Inc. as…
National Patent Development Corp.197961
*K832755Infusion Pump & IV Sets #4000
Summary page 3
…ed Date K790062 IV Administration Set with Backcheck Valve 01/10/79 04/10/79 (B. Braun Medical) K832755 OmniFlow Infusion Pump & IV Sets 08/09/83 11/03/83 K882594 OmniFlow Thera…
Omni-Glow, Inc.198316
*K882594The Omni-Flow Therapist Infusion Management System
Summary page 3
…04/10/79 (B. Braun Medical) K832755 OmniFlow Infusion Pump & IV Sets 08/09/83 11/03/83 K882594 OmniFlow Therapist Infusion System & IV Sets 06/21/88 09/20/88 K915571 Clave Connect…
Omni-Flow, Inc.19884
*K915571Clave Connector
Summary page 3
…08/09/83 11/03/83 K882594 OmniFlow Therapist Infusion System & IV Sets 06/21/88 09/20/88 K915571 Clave Connector (ICU Medical) 12/12/91 09/21/92 K944125 Abbott LTE Inf…
Icu Medical, Inc.19923
*K944125Abbott Lte Infusion Pump
Summary page 3
…V Sets 06/21/88 09/20/88 K915571 Clave Connector (ICU Medical) 12/12/91 09/21/92 K944125 Abbott LTE Infusion Pump & IV Sets 08/16/94 12/06/94 K971293 Lifeshield Pri…
Abbott Laboratories1994—

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
Nov 24, 2009Not classifiedZ-1340-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Nov 24, 2009Not classifiedZ-1384-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Nov 24, 2009Not classifiedZ-1393-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Nov 24, 2009Not classifiedZ-1387-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Nov 24, 2009Not classifiedZ-1382-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Nov 24, 2009Not classifiedZ-1383-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 5 of the 6 ancestors have 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?

The device is used with the Omni-Flow® Medication Management System for intravenous infusion by or under the order of a licensed medical practitioner. The device can be used to simultaneously infuse up to four solutions/medications from both syringes and IV fluid containers.

Indications for use as stated in the FDA summary.

More from Abbott Laboratories

1,433 FDA decisions under this applicant name. See the company

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  • P910007/S067ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92)Abbott Laboratories · 2026

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https://510kreport.com/device/K033576 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033576: Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033576

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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