510(k) · Cleared
ClearedSentinel Enteral Feeding Pump, LH2001 Enteral Feeding Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entracon Corp. · LZH Pump, Infusion, Enteral
Cleared on Jun 1, 2001 as substantially equivalent to K852965 (Empire Industries, Inc., 1985) and 1 other predicate after a 9-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.
- Decided
- Jun 1, 2001
- Review
- 9 days
- Class
- Class II
- Product code
- LZH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K852965 (1985). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K220230AMSure Enteral Feeding PumpAmsino International, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852965 | Enteral Feeding Pump | Empire Industries, Inc. | 1985 | — |
| 0 (this device) | K011587 | Sentinel Enteral Feeding Pump, LH2001 Enteral Feeding Pump | Entracon Corp. | 2001 | — |
| +1 | K220230 | AMSure Enteral Feeding Pump | Amsino International, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K852965 | Enteral Feeding PumpSummary page 1…is substantially equivalent to devices previously cleared for interstate commerce by the FDA 510(k) process. Two such devices are the KM60 reviewed under control number K852965 (08/21/1985) and the Compat-235 / -240 reviewed under control number K940555 (02/01/1995). There are no new concerns relative to… | 1985 |
| * | K940555 | Sandoz Nutrition Compat Enteral Feed Pump W/HydrationSummary page 1…merce by the FDA 510(k) process. Two such devices are the KM60 reviewed under control number K852965 (08/21/1985) and the Compat-235 / -240 reviewed under control number K940555 (02/01/1995). There are no new concerns relative to pump safety or efficacy. pg. 1 of 4 Device description The… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220230 | AMSure Enteral Feeding Pump | 2022 | 0 |
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K220230 (Amsino International, Inc., 2022) has gone furthest, with 0 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 | — |
What is it indicated for?
The enteral feeding pump accurately controls the flow of liquid feeding solution to patients who are unable or unwilling to cohsume adequate nutrients. Liquid feedings may consist of commercially prepared formulas or blenderized foods and are most often delivered by means of nasogastric, nasoduodenal of nasojenjunal feeding tubes. In some cases a surgically placed esophagostomy, gastrostomy or enterostomy tube may be used.
The pump is not intended for use with blood or blood products. The pump is not for intravenous delivery.
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/K011587 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011587: Sentinel Enteral Feeding Pump, LH2001 Enteral Feeding Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011587
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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