510(k) Report

510(k) · Cleared

Cleared

Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for Gravity and Pump Use (1000ML)

K082863510(k) TraditionalCleared Jan 9, 2009102-day reviewClass II21 CFR 876.5980

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

Dynarex Corporation · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Jan 9, 2009 as substantially equivalent to K012147 (Zevex, Inc., 2001) after a 102-day review. Its family tree reaches back 3 generations to 1985. 10 later devices descend from it.

Decided
Jan 9, 2009
Review
102 days
Class
Class II
Product code
KNT
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K851539 (1985). 5 ancestors in all. 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1986: 1 other ancestor1991: 1 other ancestor2012: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2024: 2 descendants cleared2023: 1 descendant clearedK851539 · Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap Clo · Chesebrough-Pond'S U.S.A. Co. · 1985K954735 · Enteralite · Zevex Intl., Inc. · 1996K012147 · Device Modification of Enteral Feeding Sets for Gravity and Pump Use · Zevex, Inc. · 20011990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K012147 · Device Modification of Enteral Feeding Sets for Gravity and Pump Use · Zevex, Inc. · 2001K954735 · Enteralite · Zevex Intl., Inc. · 1996K851539 · Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap Clo · Chesebrough-Pond'S U.S.A. Co. · 19850+5
  1. Root · 3 generations backK851539 Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloChesebrough-Pond'S U.S.A. Co. · 1985
  2. 2 generations backK954735 EnteraliteZevex Intl., Inc. · 1996
  3. 1 generation backK012147 Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc. · 2001
  4. This deviceK082863 Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex…Dynarex Corporation · 2009
  5. Descendant · cites it directly · 8 of its ownK133077 Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set…Generica Medical International, Inc. · 2014
  6. Descendant · 2 generations on · 7 of its ownK150286 Medline Enteral Feeding SetsMedline Industries, Inc. · 2015
  7. Descendant · 3 generations on · 2 of its ownK163586 Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit…Trovrx, Inc. Dba Trovita Health Science · 2017
  8. Descendant · 3 generations on · 1 of its ownK222678 Mobility+ Enteral Feeding SystemRockfield Medical · 2022
  9. Descendant · 4 generations on · 1 of its ownK210971 EnteraLoc FlowVonco Products · 2021

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2012: 12014: 12015: 12017: 12018: 12021: 12022: 12023: 12024: 2
2012high 2 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 10 · See all
  • K133077Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag SetGenerica Medical International, Inc. · 2014 · cites it directly8descendants
  • K150286Medline Enteral Feeding SetsMedline Industries, Inc. · 2015 · 2 generations on7descendants
  • K163586Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit ConnectorTrovrx, Inc. Dba Trovita Health Science · 2017 · 3 generations on2descendants
  • K222678Mobility+ Enteral Feeding SystemRockfield Medical · 2022 · 3 generations on1descendant
  • K210971EnteraLoc FlowVonco Products · 2021 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K851539Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloChesebrough-Pond'S U.S.A. Co.1985—
−2K954735EnteraliteZevex Intl., Inc.1996—
−1K012147Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc.2001—
0 (this device)K082863Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding…Dynarex Corporation2009—
+1K133077Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag…Generica Medical International, Inc.2014—
+2K150286Medline Enteral Feeding SetsMedline Industries, Inc.2015—
+3K163586Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit ConnectorTrovrx, Inc. Dba Trovita Health Science2017—
+3K222678Mobility+ Enteral Feeding SystemRockfield Medical2022—
+4K210971EnteraLoc FlowVonco Products2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
201510
201710
201810
202110
202210
202310
202420
FIG. 1 — Lineage of K082863, 1985–2024Source: 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 KNT? 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 KNT device

  1. #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 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? (1)

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
*K012147Device Modification of Enteral Feeding Sets for Gravity and Pump Use
Summary page 1
…Gastrointestinal tube and accessories. Predicate Device Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use ( K012147) Device Description/ Comparison Dynarex is substantially equivalent in safety and effectivene…
Zevex, Inc.2001—

Also cleared against K012147: 1 other device →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K133077Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag SetGenerica Medical International, Inc.20148
K112863Enteral Administration Set with Solution Container, Enteral Administration Set, Enteral…Acta Medical, LLC20120

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?

  • The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K133077 (Generica Medical International, Inc., 2014) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K012147.

How does its category compare?

All KNT devices

KNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · KNT

4in 2025

2007: 102008: 102009: 112010: 122011: 72012: 122013: 72014: 162015: 102016: 62017: 92018: 72019: 102020: 52021: 62022: 72023: 52024: 92025: 42026 (partial year): 3
2007high 16 (2014) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNT

136in 2025

2007: 118 days median2008: 115 days median2009: 102 days median2010: 104 days median2011: 211 days median2012: 107 days median2013: 128 days median2014: 259 days median2015: 140 days median2016: 99 days median2017: 247 days median2018: 149 days median2019: 126 days median2020: 102 days median2021: 121 days median2022: 110 days median2023: 162 days median2024: 103 days median2025: 136 days median2026 (partial year): 105 days median
2007high 259 (2014) · low 99 (2016)2026

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

Recalls per year · KNT

13in 2025

2007: 12008: 822009: 92010: 32011: 22012: 12015: 12016: 32017: 42018: 22019: 22020: 12021: 22022: 1, 1 Class I2023: 22025: 132026 (partial year): 20
2007high 82 (2008) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KNT

1,451in 2025

2007: 3002008: 8672009: 8182010: 5172011: 5312012: 5282013: 7472014: 1,0302015: 1,0482016: 1,2512017: 1,6722018: 1,9012019: 1,8382020: 1,6412021: 1,6552022: 1,6502023: 1,8632024: 1,3442025: 1,451
2007high 1,901 (2018) · low 300 (2007)2025

MAUDE reports naming product code KNT, 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
2007101181300
20081011582867
2009111029818
2010121043517
201172112531
2012121071528
201371280747
20141625901,030
20151014011,048
201669931,251
2017924741,672
2018714921,901
20191012621,838
2020510211,641
2021612121,655
202271101 (1)1,650
2023516221,863
2024910301,344
20254136131,451
2026310520—

What is it indicated for?

The devices in this product family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike, to connect to a pre-filled container. These devices are food contacting.

Indications for use as stated in the FDA summary.

Also cleared against K012147

1 other device cites the same predicate.

  • K142539EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery SetZevex, Inc. · 20151 recall

More from Dynarex Corporation

8 FDA decisions under this applicant name. See the company

  • K172266Dynarex Three-Way StopcockDynarex Corporation · 2018
  • K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation · 2016
  • K151575Dynarex Eye CupsDynarex Corporation · 2015
  • K103086Dynarex Intermittent Catheters, Male, Female, PediatricDynarex Corporation · 2011
  • K102637Dynarex Ultrasound GelDynarex Corporation · 2011

Recent decisions in KNT

The KNT category page

  • K262038danumed StomaMeterDanumed Medizintechnik GmbH · 2026
  • K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2025
  • K243228Flexi-Seal AIR (with ENFit Connector)Convatec · 2025

https://510kreport.com/device/K082863 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082863: Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for Gravity and Pump Use (1000ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082863

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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