510(k) · Cleared
Recalled · 2003Sandoz Nutrition Compat Enteral Feed Pump W/Hydration
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sandoz Nutrition · LZH Pump, Infusion, Enteral
Cleared on Feb 1, 1995 after a 359-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it. It has been recalled once.
- Decided
- Feb 1, 1995
- Review
- 359 days
- Class
- Class II
- Product code
- LZH
- Recalls
- 1
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK940555 Sandoz Nutrition Compat Enteral Feed Pump W/HydrationSandoz Nutrition · 1995
- Descendant · cites it directly · 10 of its ownK080340 Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing…Novartis Nutrition Corp. · 2008
- Descendant · 2 generations on · 8 of its ownK140581 Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral…Cedic S.R.L. · 2014
- Descendant · 3 generations on · 1 of its ownK150034 AMT Enteral Transition AdaptersApplied Medical Technology, Inc. · 2015 · Recalled
- Descendant · cites it directly · 1 of its ownK011587 Sentinel Enteral Feeding Pump, LH2001 Enteral Feeding PumpEntracon Corp. · 2001
- Descendant · 3 generations on · 0 of its ownK253268 Profoject Enteral/Oral Feeding Syringe; Profoject Reusable…CMT Health PTE., Ltd. · 2026
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K080340Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing Spike and 1000 ML Waer…Novartis Nutrition Corp. · 2008 · cites it directly10descendants
- K140581Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition…Cedic S.R.L. · 2014 · 2 generations on8descendants
- K150034AMT Enteral Transition AdaptersApplied Medical Technology, Inc. · 2015 · 3 generations on1descendant
- K011587Sentinel Enteral Feeding Pump, LH2001 Enteral Feeding PumpEntracon Corp. · 2001 · cites it directly1descendant
- K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe…CMT Health PTE., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940555 | Sandoz Nutrition Compat Enteral Feed Pump W/Hydration | Sandoz Nutrition | 1995 | — |
| +1 | K080340 | Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing Spike and… | Novartis Nutrition Corp. | 2008 | — |
| +2 | K140581 | Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit… | Cedic S.R.L. | 2014 | — |
| +3 | K150034 | AMT Enteral Transition Adapters | Applied Medical Technology, Inc. | 2015 | 1 |
| +1 | K011587 | Sentinel Enteral Feeding Pump, LH2001 Enteral Feeding Pump | Entracon Corp. | 2001 | — |
| +3 | K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral… | CMT Health PTE., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
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 LZH? 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 LZH device
- #1 K253558 Luminoah FLOW™ Enteral Nutrition Systemscore 13.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 27, 2003 | Not classified | Z-0609-03 | Other | Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080340 (Novartis Nutrition Corp., 2008) has gone furthest, with 10 descendants of its own.
How does its category compare?
All LZH devicesLZH Pump, Infusion, Enteral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZH
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LZH
Too few LZH 510(k)s in any year since 2007 to give a median.
Recalls per year · LZH
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZH
376in 2025
MAUDE reports naming product code LZH, 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 | — | 2 | 1,150 |
| 2008 | 0 | — | 3 | 858 |
| 2009 | 0 | — | 1 | 124 |
| 2010 | 0 | — | 0 | 220 |
| 2011 | 0 | — | 1 | 274 |
| 2012 | 1 | — | 2 | 398 |
| 2013 | 0 | — | 0 | 349 |
| 2014 | 2 | — | 0 | 119 |
| 2015 | 1 | — | 0 | 83 |
| 2016 | 1 | — | 0 | 1,248 |
| 2017 | 0 | — | 0 | 2,620 |
| 2018 | 0 | — | 0 | 1,652 |
| 2019 | 0 | — | 0 | 742 |
| 2020 | 1 | — | 2 | 1,460 |
| 2021 | 0 | — | 0 | 1,218 |
| 2022 | 2 | — | 0 | 526 |
| 2023 | 1 | — | 0 | 284 |
| 2024 | 0 | — | 0 | 319 |
| 2025 | 0 | — | 0 | 376 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K940555 · printed Nov 4, 2026
Cite this page
510(k) Report. “K940555: Sandoz Nutrition Compat Enteral Feed Pump W/Hydration.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940555
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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