510(k) · Cleared
Recalled · 2007Clearstar Enteral Nutrition Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Frantz Medical Development, Ltd. · LZH Pump, Infusion, Enteral
Cleared on Aug 13, 1998 after a 106-day review. The FDA summary names no predicate by number. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 13, 1998
- Review
- 106 days
- Class
- Class II
- Product code
- LZH
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK981541 Clearstar Enteral Nutrition PumpFrantz Medical Development, Ltd. · 1998
- Descendant · cites it directly · 0 of its ownK060316 Compat GO Enteral Feeding Pump and Administration SetsFresenius Kabi Deutschland GmbH · 2006
Most influential descendants
Showing 1 of 1 · See all- K060316Compat GO Enteral Feeding Pump and Administration SetsFresenius Kabi Deutschland GmbH · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981541 | Clearstar Enteral Nutrition Pump | Frantz Medical Development, Ltd. | 1998 | — |
| +1 | K060316 | Compat GO Enteral Feeding Pump and Administration Sets | Fresenius Kabi Deutschland GmbH | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K060316 | Compat GO Enteral Feeding Pump and Administration Sets | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 21, 2007 | Not classified | Z-1142-2007 | Equipment maintenance | The transducer adapter bracket on the pump could crack or break and potentially result in under delivery of the enteral product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060316 (Fresenius Kabi Deutschland GmbH, 2006) 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 ClearStar pump can be used for adult and pediatric patients provided the patients can tolerate a feeding range within the pump operational specifications. Those specifications are: * The flow rate range is 1-300 mL/hr in 1 mL/hr increments * The flow rate accuracy is ± 10% or ± 0.5 mL/hr, whichever is greater * The occlusion pressure limit is 26-30 psi. If these specifications are not appropriate for a given patient, the ClearStar pump should not be…
Read the full statement (191 words)
The ClearStar pump can be used for adult and pediatric patients provided the patients can tolerate a feeding range within the pump operational specifications. Those specifications are:
* The flow rate range is 1-300 mL/hr in 1 mL/hr increments
* The flow rate accuracy is ± 10% or ± 0.5 mL/hr, whichever is greater
* The occlusion pressure limit is 26-30 psi.
If these specifications are not appropriate for a given patient, the ClearStar pump should not be used.
Precautions
All enteral pumps have the potential to bolus-feed or over deliver, which is an important consideration in feeding volume-sensitive patients. In these patients, a volume of product no more than four times the hourly feeding rate should be hung.
Confirm proper placement and function.
Confirm proper placement and function of patient’s enteral feeding tube (nasogastric, jejunostomy, gastrostomy, etc.), and verify the following before initiating feeding:
A ClearStar Pump Set is being used.
Cassette is properly seated in pump.
When on AC power, pump is fully seated in charger.
Flow rate is set at the prescribed mL/hr.
Pump dial is turned to RUN.
Note: The Power Supply Cord is the DISCONNECT DEVICE.
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/K981541 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981541: Clearstar Enteral Nutrition Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981541
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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