510(k) Report

510(k) · Cleared

Cleared

Lifeport Infusion Set and Infusion Set W/ Y Site

K921674510(k) TraditionalCleared Sep 23, 1992168-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

Strato Medical Corp. · FPA Set, Administration, Intravascular

Cleared on Sep 23, 1992 after a 168-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it.

Decided
Sep 23, 1992
Review
168 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2007: 2 descendants cleared2004: 1 descendant cleared2003: 1 descendant cleared2009: 2 descendants cleared2008: 2 descendants cleared2011: 3 descendants cleared2016: 1 descendant cleared2017: 2 descendants cleared2014: 1 descendant cleared2021: 3 descendants cleared2023: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared2025: 2 descendants cleared1990200020102020
  1. This deviceK921674 Lifeport Infusion Set and Infusion Set W/ Y SiteStrato Medical Corp. · 1992
  2. Descendant · cites it directly · 24 of its ownK013871 Lifeguard Safety Infusion SetHorizon Medical Products, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 20 of its ownK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
  4. Descendant · 3 generations on · 13 of its ownK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
  5. Descendant · 4 generations on · 6 of its ownK170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety…B.Braun Medical, Inc. · 2017
  6. Descendant · 3 generations on · 5 of its ownK072375 Smartport CT MP Port Access System and Lifeguard CT Safety Infusion…AngioDynamics, Inc. · 2007

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 12007: 22008: 22009: 22011: 32014: 12016: 12017: 22020: 12021: 32023: 12024: 12025: 22026: 1
2002high 3 (2011) · low 0 (2005)2026

Most influential descendants

Showing 5 of 25 · See all
  • K013871Lifeguard Safety Infusion SetHorizon Medical Products, Inc. · 2002 · cites it directly24descendants
  • K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · 2 generations on20descendants
  • K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · 3 generations on13descendants
  • K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc. · 2017 · 4 generations on6descendants
  • K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc. · 2007 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921674Lifeport Infusion Set and Infusion Set W/ Y SiteStrato Medical Corp.1992—
+1K013871Lifeguard Safety Infusion SetHorizon Medical Products, Inc.20023
+2K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc.20072
+3K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.20082
+4K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle…B.Braun Medical, Inc.2017—
+3K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200410
200720
200820
200920
201130
201410
201610
201720
202010
202130
202310
202410
202520
202610
FIG. 1 — Lineage of K921674, 1992–2026Source: 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? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K013871Lifeguard Safety Infusion SetHorizon Medical Products, Inc.200224

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K013871 (Horizon Medical Products, Inc., 2002) has gone furthest, with 24 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 Strato Medical Corp.

48 FDA decisions under this applicant name. See the company

  • K945956Strato Medical Infuse-a-Cath Triple Lumen Silicone Catheter SystemsStrato Medical Corp. · 1995
  • K946250Strato Medical Infuse-a-Cath, Triple Lumen Polyurethane, Central Vnous Catheter SystemsStrato Medical Corp. · 1995
  • K942848Strato Medical Lifeport LPS 7515Strato Medical Corp. · 1995
  • K934518Strato Medical Infuse-a-Port/Infuse-a-Kit Periport Peripheral Access SystemStrato Medical Corp. · 1995
  • K932509Strato Medical Infuse-a-Port/Snap-Lock MacroprortStrato Medical Corp. · 1994

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https://510kreport.com/device/K921674 · printed Nov 5, 2026

Cite this page

510(k) Report. “K921674: Lifeport Infusion Set and Infusion Set W/ Y Site.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K921674

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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