510(k) · Cleared
ClearedAMSure Enteral Feeding Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amsino International, Inc. · LZH Pump, Infusion, Enteral
Cleared on Nov 10, 2022 as substantially equivalent to K011587 (Entracon Corp., 2001) after a 287-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Nov 10, 2022
- Review
- 287 days
- Class
- Class II
- Product code
- LZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K852965 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852965 | Enteral Feeding Pump | Empire Industries, Inc. | 1985 | — |
| −1 | K011587 | Sentinel Enteral Feeding Pump, LH2001 Enteral Feeding Pump | Entracon Corp. | 2001 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K011587 | Sentinel Enteral Feeding Pump, LH2001 Enteral Feeding PumpSummary page 4…21 CFR880. 5725 Product Code: LZH Device Class: Class II Predicate Device(s): SENTINEL Enteral Feeding pump (K011587) Device Description: The AMSure® enteral feeding pump is intended to work with the disposable enteral feeding sets that deliver… | 2001 |
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 37 years and passes through 3 companies; a new generation was cleared every 21.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All LZH devicesLZH Pump, Infusion, Enteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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 AMSure® Enteral Feeding Pump is intended to work with the disposable enteral feeding sets to deliver nutritional formula to the gastrointestinal system of adult patients who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing.
Only intended for adult patients, not for pediatric use.
The AMSure® Enteral feeding pump is intended to be used in healthcare facilities by licensed healthcare professional users only.
The AMSure® Enteral feeding pump is for use only with Amsino AMSure® feeding sets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220230: AMSure Enteral Feeding Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220230
Report an extraction error
Are you the manufacturer?
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