510(k) Report

510(k) · Cleared

Cleared

Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing Spike and 1000 ML Waer Bag

K080340510(k) SpecialCleared Mar 5, 200826-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

Novartis Nutrition Corp. · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Mar 5, 2008 as substantially equivalent to K940555 (Sandoz Nutrition, 1995) and 1 other predicate after a 26-day review. Its family tree reaches back 1 generation to 1994. 10 later devices descend from it.

Decided
Mar 5, 2008
Review
26 days
Class
Class II
Product code
KNT
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K940556 (1994). 2 ancestors in all. 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2014: 2 descendants cleared2015: 3 descendants cleared2016: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant cleared2017: 1 descendant clearedK940556 · Sandoz Nutrition Compat (R) Enteral Feeding Pump · Sandoz Nutrition · 1994 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 7 descendants3 generations forward: 1 descendant K940556 · Sandoz Nutrition Compat (R) Enteral Feeding Pump · Sandoz Nutrition · 1994 · recalled0
  1. Root · 1 generation backK940556 Sandoz Nutrition Compat (R) Enteral Feeding PumpSandoz Nutrition · 1994 · Recalled
  2. This deviceK080340 Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing…Novartis Nutrition Corp. · 2008
  3. Descendant · cites it directly · 8 of its ownK140581 Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral…Cedic S.R.L. · 2014
  4. Descendant · 2 generations on · 1 of its ownK150034 AMT Enteral Transition AdaptersApplied Medical Technology, Inc. · 2015 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK253268 Profoject Enteral/Oral Feeding Syringe; Profoject Reusable…CMT Health PTE., Ltd. · 2026
  6. Descendant · 2 generations on · 0 of its ownK231299 Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree…Cair Lgl · 2024
  7. Descendant · 2 generations on · 0 of its ownK233190 ENFit AdaptorJiangsu Caina Medical Co.,Ltd · 2024

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2014: 22015: 32016: 12017: 12024: 22026: 1
2014high 3 (2015) · low 0 (2018)2026

Most influential descendants

Showing 5 of 10 · See all
  • K140581Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition…Cedic S.R.L. · 2014 · cites it directly8descendants
  • K150034AMT Enteral Transition AdaptersApplied Medical Technology, Inc. · 2015 · 2 generations on1descendant
  • K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe…CMT Health PTE., Ltd. · 2026 · 2 generations on0descendants
  • K231299Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connectorCair Lgl · 2024 · 2 generations on0descendants
  • K233190ENFit AdaptorJiangsu Caina Medical Co.,Ltd · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K940556Sandoz Nutrition Compat (R) Enteral Feeding PumpSandoz Nutrition19942
0 (this device)K080340Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing Spike and…Novartis Nutrition Corp.2008—
+1K140581Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit…Cedic S.R.L.2014—
+2K150034AMT Enteral Transition AdaptersApplied Medical Technology, Inc.20151
+2K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral…CMT Health PTE., Ltd.2026—
+2K231299Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connectorCair Lgl2024—
+2K233190ENFit AdaptorJiangsu Caina Medical Co.,Ltd2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201530
201610
201710
202420
202610
FIG. 1 — Lineage of K080340, 1994–2026Source: 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), 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? (2)

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
*K940555Sandoz Nutrition Compat Enteral Feed Pump W/Hydration
Summary page 1
…21CFR§ 876.5980 Class: II Product Code: KNT Equivalent marketed device: K940555 - Sandoz Nutrition COMPAT Enteral Feeding Pump with Hydration K940556 - Sandoz N…
Sandoz Nutrition19951
*K940556Sandoz Nutrition Compat (R) Enteral Feeding Pump
Summary page 1
…NT Equivalent marketed device: K940555 - Sandoz Nutrition COMPAT Enteral Feeding Pump with Hydration K940556 - Sandoz Nutrition COMPAT Enteral Feeding Pump Nestl Healthcare Nutrition, Inc. Confidential…
Sandoz Nutrition19942

Also cleared against K940555: 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
K140581Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition…Cedic S.R.L.20148
K140947Compat Enteral Delivery Pump SetsNestle Healthcare Nutrition, Inc.20140

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?

  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K140581 (Cedic S.R.L., 2014) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K940555.

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. 2008, 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 COMPAT® Enteral Delivery Pump Sets are intended to deliver liquid nutrition formulas or hydration to an enteral access device (a feeding tube).

Indications for use as stated in the FDA summary.

Also cleared against K940555

1 other device cites the same predicate.

  • K011587Sentinel Enteral Feeding Pump, LH2001 Enteral Feeding PumpEntracon Corp. · 2001

More from Novartis Nutrition Corp.

5 FDA decisions under this applicant name. See the company

  • K071191Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube KitNovartis Nutrition Corp. · 2007
  • K001916Compat Replacement Gastrostomy Tube Kit, Model 0974XXNovartis Nutrition Corp. · 2001
  • K991668Compat Jejunostomy Tube Kit, Model 088OXX (XX=16,14, or 12)Novartis Nutrition Corp. · 1999
  • K981323Compat Mini-G Replacement Gastrostomy TubeNovartis Nutrition Corp. · 1998

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/K080340 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080340: Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing Spike and 1000 ML Waer Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080340

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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