510(k) Report

510(k) · Cleared

Cleared

Twofer Needle

K832347510(k) TraditionalCleared Sep 12, 198356-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

Baxa Corp., Sub. of Cook Group, Inc. · LHI Set, I.V. Fluid Transfer

Cleared on Sep 12, 1983 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Sep 12, 1983
Review
56 days
Class
Class II
Product code
LHI
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared19801990200020102020
  1. This deviceK832347 Twofer NeedleBaxa Corp., Sub. of Cook Group, Inc. · 1983
  2. Descendant · cites it directly · 0 of its ownK132011 Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer SetAea Srl · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K132011Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer SetAea Srl · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K832347Twofer NeedleBaxa Corp., Sub. of Cook Group, Inc.1983—
+1K132011Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer SetAea Srl2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K832347, 1983–2014Source: 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 LHI? 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 LHI device

  1. #1 K252987 ADRx™ Admixture Devicescore 12.4 · 4 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K132011Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer SetAea Srl20140

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, K132011 (Aea Srl, 2014) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LHI devices

LHI Set, I.V. Fluid Transfer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LHI

6in 2025

2007: 32008: 42009: 82010: 52011: 32012: 52013: 42014: 62015: 32016: 32017: 52018: 12019: 42020: 32021: 32022: 62023: 52024: 92025: 62026 (partial year): 2
2007high 9 (2024) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LHI

196in 2025

2007: 89 days median2008: 154 days median2009: 95 days median2010: 139 days median2011: 99 days median2012: 127 days median2013: 102 days median2014: 63 days median2015: 99 days median2016: 159 days median2017: 56 days median2019: 247 days median2020: 189 days median2021: 396 days median2022: 278 days median2023: 90 days median2024: 166 days median2025: 196 days median
2007high 396 (2021) · low 56 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LHI

1in 2024

2007: 12008: 32009: 12010: 32011: 122013: 32016: 1, 1 Class I2017: 12018: 3, 3 Class I2019: 12022: 22023: 2, 2 Class I2024: 12026 (partial year): 1
2007high 12 (2011) · low 0 (2012)2026

Class I (6 since 2007) Class II/III not classified

Adverse event reports per year · LHI

1,334in 2025

2007: 182008: 272009: 372010: 492011: 1552012: 5292013: 1542014: 1552015: 1282016: 2192017: 5362018: 1,4992019: 1,6342020: 1,1712021: 9332022: 1,8342023: 1,0472024: 1,2702025: 1,334
2007high 1,834 (2022) · low 18 (2007)2025

MAUDE reports naming product code LHI, 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
2007389118
20084154327
2009895137
20105139349
201139912155
201251270529
201341023154
20146630155
20153990128
201631591 (1)219
20175561536
20181—3 (3)1,499
2019424711,634
2020318901,171
202133960933
2022627821,834
20235902 (2)1,047
2024916611,270
2025619601,334
20262—1—

More from Baxa Corp., Sub. of Cook Group, Inc.

16 FDA decisions under this applicant name. See the company

  • K910257Baxa Pca InfusorBaxa Corp., Sub. of Cook Group, Inc. · 1991
  • K903159Valve Controller for Micromacro CompounderBaxa Corp., Sub. of Cook Group, Inc. · 1990
  • K904225KwikmixBaxa Corp., Sub. of Cook Group, Inc. · 1990
  • K900585Tubing Sets for Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. · 19901 Class I recall
  • K873875Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. · 1987

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https://510kreport.com/device/K832347 · printed Nov 4, 2026

Cite this page

510(k) Report. “K832347: Twofer Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K832347

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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