510(k) · Cleared
ClearedCompat Enteral Delivery Pump Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nestle Healthcare Nutrition, Inc. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Sep 4, 2014 as substantially equivalent to K080340 (Novartis Nutrition Corp., 2008) after a 143-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Sep 4, 2014
- Review
- 143 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940556 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK940556 Sandoz Nutrition Compat (R) Enteral Feeding PumpSandoz Nutrition · 1994 · Recalled
- 1 generation backK080340 Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing…Novartis Nutrition Corp. · 2008
- This deviceK140947 Compat Enteral Delivery Pump SetsNestle Healthcare Nutrition, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940556 | Sandoz Nutrition Compat (R) Enteral Feeding Pump | Sandoz Nutrition | 1994 | 2 |
| −1 | K080340 | Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing Spike and… | Novartis Nutrition Corp. | 2008 | — |
| 0 (this device) | K140947 | Compat Enteral Delivery Pump Sets | Nestle Healthcare Nutrition, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
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 PIF? 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 PIF device
- #1 K253715 Edi Catheter ENFit 6Fr/48 cm (6893166); Edi…score 15.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080340 | Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing Spike and 1000 ML Waer…Summary page 4…ate Device(s): COMPAT DuaIFlo® Enteral Delivery Pump Set with SpikeRight Piercing Spike and 1000 mL Water Bag K080340 Device Description: Five configurations of enteral delivery sets: Standard Bag, Standard… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K080340.
How does its category compare?
All PIF devicesPIF Gastrointestinal Tubes With Enteral Specific Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PIF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PIF
242in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PIF
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PIF
83in 2025
MAUDE reports naming product code PIF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 119 | 0 | 0 |
| 2015 | 9 | 143 | 106 | 12 |
| 2016 | 3 | 267 | 0 | 45 |
| 2017 | 5 | 174 | 0 | 17 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 7 | 135 | 0 | 28 |
| 2020 | 4 | 165 | 0 | 70 |
| 2021 | 4 | 242 | 0 | 89 |
| 2022 | 4 | 167 | 0 | 77 |
| 2023 | 4 | 242 | 0 | 96 |
| 2024 | 2 | — | 1 | 110 |
| 2025 | 2 | — | 0 | 83 |
| 2026 | 3 | 239 | 0 | — |
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140947: Compat Enteral Delivery Pump Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140947
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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