510(k) Report

510(k) · Cleared

Cleared

Enteral Feeding Sets for Gravity and Pump Use

K862489510(k) TraditionalCleared Sep 23, 198685-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

Knight Medical, Inc. · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Sep 23, 1986 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.

Decided
Sep 23, 1986
Review
85 days
Class
Class II
Product code
KNT
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared2015: 2 descendants cleared2009: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2021: 2 descendants cleared2024: 3 descendants cleared2018: 1 descendant cleared2022: 1 descendant cleared2017: 1 descendant cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK862489 Enteral Feeding Sets for Gravity and Pump UseKnight Medical, Inc. · 1986
  2. Descendant · cites it directly · 14 of its ownK012147 Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc. · 2001
  3. Descendant · 2 generations on · 10 of its ownK082863 Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex…Dynarex Corporation · 2009
  4. Descendant · 3 generations on · 8 of its ownK133077 Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set…Generica Medical International, Inc. · 2014
  5. Descendant · 4 generations on · 7 of its ownK150286 Medline Enteral Feeding SetsMedline Industries, Inc. · 2015
  6. Descendant · 5 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

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2001: 12009: 12012: 12014: 12015: 22017: 12018: 12021: 22022: 12023: 12024: 3
2001high 3 (2024) · low 0 (2002)2026

Most influential descendants

Showing 5 of 15 · See all
  • K012147Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc. · 2001 · cites it directly14descendants
  • K082863Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for…Dynarex Corporation · 2009 · 2 generations on10descendants
  • K133077Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag SetGenerica Medical International, Inc. · 2014 · 3 generations on8descendants
  • K150286Medline Enteral Feeding SetsMedline Industries, Inc. · 2015 · 4 generations on7descendants
  • K163586Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit ConnectorTrovrx, Inc. Dba Trovita Health Science · 2017 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K862489Enteral Feeding Sets for Gravity and Pump UseKnight Medical, Inc.1986—
+1K012147Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc.2001—
+2K082863Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding…Dynarex Corporation2009—
+3K133077Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag…Generica Medical International, Inc.2014—
+4K150286Medline Enteral Feeding SetsMedline Industries, Inc.2015—
+5K163586Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit ConnectorTrovrx, Inc. Dba Trovita Health Science2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200910
201210
201410
201520
201710
201810
202120
202210
202310
202430
FIG. 1 — Lineage of K862489, 1986–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K012147Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc.200114

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, K012147 (Zevex, Inc., 2001) has gone furthest, with 14 descendants of its own.

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.

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—

More from Knight Medical, Inc.

5 FDA decisions under this applicant name. See the company

  • K921127Panda Needle Catheter Jejunostomy KitKnight Medical, Inc. · 1993
  • K903086Tube GastrostomyKnight Medical, Inc. · 1990
  • K883848Kmi Oxy-BanKnight Medical, Inc. · 1989
  • K883886Double Closed Urinary Drainage SystemKnight Medical, Inc. · 1988

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/K862489 · printed Nov 4, 2026

Cite this page

510(k) Report. “K862489: Enteral Feeding Sets for Gravity and Pump Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862489

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026