510(k) · Cleared
ClearedEnteral Expres Pump Unit, Enteral Expres Giving Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Debio Tech SA · LZH Pump, Infusion, Enteral
Cleared on Sep 4, 2001 as substantially equivalent to K945964 (Sherwood Medical Co., 1995) after an 82-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 4, 2001
- Review
- 82 days
- Class
- Class II
- Product code
- LZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945964 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK945964 Kangaroo (R) 524 Enteral Feeding Pump and Administration SetsSherwood Medical Co. · 1995
- This deviceK011868 Enteral Expres Pump Unit, Enteral Expres Giving SetsDebio Tech SA · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945964 | Kangaroo (R) 524 Enteral Feeding Pump and Administration Sets | Sherwood Medical Co. | 1995 | — |
| 0 (this device) | K011868 | Enteral Expres Pump Unit, Enteral Expres Giving Sets | Debio Tech SA | 2001 | — |
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 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? (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 |
|---|---|---|---|
| * | K945964 | Kangaroo (R) 524 Enteral Feeding Pump and Administration SetsSummary page 1…assification name: LZH - External Enteral Infusion Pump FPA — Intravascular (IV) Administration Set Substantial equivalence claimed to: Sherwood Medical Kangaroo Pump — K945964 Description: The Enteral Exprés enteral feeding pump system is intended for the programmed delivery of enteral nutrition fluids… | 1995 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K945964.
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 | — |
What is it indicated for?
The Enteral Exprés enteral fluid delivery system is intended to provide delivery of standard enteral nutrition fluids to patients in the hospital and in alternate site care.
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/K011868 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011868: Enteral Expres Pump Unit, Enteral Expres Giving Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011868
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026