510(k) Report

510(k) · Cleared

Cleared

Baxa Tubing Sets (for Pharmacy Pump)

K872743510(k) TraditionalCleared Oct 9, 198788-day reviewClass II21 CFR 880.5860

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. · FMF Syringe, Piston

Cleared on Oct 9, 1987 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Oct 9, 1987
Review
88 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 1 descendant cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK872743 Baxa Tubing Sets (for Pharmacy Pump)Baxa Corp., Sub. of Cook Group, Inc. · 1987
  2. Descendant · cites it directly · 1 of its ownK062909 Repeater Pump II Tube SetsBaxa Corp. · 2007
  3. Descendant · 2 generations on · 0 of its ownK200893 ProntoPump Sterile Tube SetIpax, Inc. · 2021

Most influential descendants

Showing 2 of 2 · See all
  • K062909Repeater Pump II Tube SetsBaxa Corp. · 2007 · cites it directly1descendant
  • K200893ProntoPump Sterile Tube SetIpax, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K872743Baxa Tubing Sets (for Pharmacy Pump)Baxa Corp., Sub. of Cook Group, Inc.1987—
+1K062909Repeater Pump II Tube SetsBaxa Corp.2007—
+2K200893ProntoPump Sterile Tube SetIpax, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
202110
FIG. 1 — Lineage of K872743, 1987–2021Source: 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 FMF? 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 FMF device

  1. #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K062909Repeater Pump II Tube SetsBaxa Corp.20071

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, K062909 (Baxa Corp., 2007) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMF

13in 2025

2007: 232008: 92009: 142010: 112011: 162012: 92013: 122014: 132015: 112016: 122017: 132018: 82019: 112020: 152021: 202022: 242023: 222024: 142025: 132026 (partial year): 9
2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007: 90 days median2008: 74 days median2009: 94 days median2010: 130 days median2011: 109 days median2012: 86 days median2013: 154 days median2014: 84 days median2015: 87 days median2016: 146 days median2017: 135 days median2018: 87 days median2019: 146 days median2020: 107 days median2021: 175 days median2022: 211 days median2023: 173 days median2024: 130 days median2025: 114 days median2026 (partial year): 239 days median
2007high 239 (2026) · low 74 (2008)2026

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

Recalls per year · FMF

19in 2023

2007: 62008: 112009: 152010: 122011: 32012: 62013: 12014: 12015: 22017: 32018: 22019: 12020: 22021: 12022: 22023: 19, 18 Class I2026 (partial year): 2, 1 Class I
2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007: 6742008: 6912009: 9132010: 6792011: 1862012: 3072013: 3262014: 2442015: 2732016: 6842017: 1,8582018: 3,9522019: 5,8632020: 5,3342021: 5,8742022: 5,2332023: 5,2142024: 5,1222025: 4,181
2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, 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
200723906674
200897411691
2009149415913
20101113012679
2011161093186
20129866307
2013121541326
201413841244
201511872273
2016121460684
20171313531,858
201888723,952
20191114615,863
20201510725,334
20212017515,874
20222421125,233
20232217319 (18)5,214
20241413005,122
20251311404,181
202692392 (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

Recent decisions in FMF

The FMF category page

  • K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026
  • K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc. · 2026
  • K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd. · 2026
  • K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC · 2026
  • K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026

https://510kreport.com/device/K872743 · printed Nov 6, 2026

Cite this page

510(k) Report. “K872743: Baxa Tubing Sets (for Pharmacy Pump).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872743

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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