510(k) · Cleared
ClearedCompat GO Enteral Feeding Pump and Administration Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Kabi Deutschland GmbH · LZH Pump, Infusion, Enteral
Cleared on Jun 23, 2006 as substantially equivalent to K954735 (Zevex Intl., Inc., 1996) and 2 other predicates after a 135-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Jun 23, 2006
- Review
- 135 days
- Class
- Class II
- Product code
- LZH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K851539 (1985). 6 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 | K851539 | Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap Clo | Chesebrough-Pond'S U.S.A. Co. | 1985 | — |
| −1 | K954735 | Enteralite | Zevex Intl., Inc. | 1996 | — |
| 0 (this device) | K060316 | Compat GO Enteral Feeding Pump and Administration Sets | Fresenius Kabi Deutschland GmbH | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 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? (3)
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 |
|---|---|---|---|
| * | K954735 | EnteraliteSummary page 1…he currently marked Enteral Feeding Pumps and Administration Sets: 510kjNumbe Name Applicant K954735 Enteralite Zexex Intl. Inc. K981541 ClearStar… | 1996 |
| * | K981541 | Clearstar Enteral Nutrition PumpSummary page 1…510kjNumbe Name Applicant K954735 Enteralite Zexex Intl. Inc. K981541 ClearStar Frantz Medical Devel. K040 196 Kendall (Kangaroo)… | 1998 |
| * | K040196 | Kendall Epump Enteral Feeding Pump and Enteral Feeding SetsSummary page 1…4735 Enteralite Zexex Intl. Inc. K981541 ClearStar Frantz Medical Devel. K040 196 Kendall (Kangaroo) Tyco Healtlicare/Kendali Control 4.… | 2004 |
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 21 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K954735.
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 Compat GO M T feeding pump with the administration sets are intended exclusively for eriterat feeding
The purpose of this administration system is the delivery of Enleial nutrition at controlled rates (pump assisted) to patienils gastmintestinal svstenm Intended for us tbr patijenit withi any curditdion requiring EnteralI feeding and Enteral hydration.
The Cornpat GO' Entenul Feeding Puimp and the Comnpat GO;IMneral Administration Sets are intended to use by adults or paediatic im}spilal aand home care env211i'omiiets, both in stationalvtand ambulatory way¥s
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060316: Compat GO Enteral Feeding Pump and Administration Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060316
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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