510(k) · Cleared
ClearedMedi-Sis Syringe Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acacia, Inc. · LZH Pump, Infusion, Enteral
Cleared on Jan 13, 2012 as substantially equivalent to K953028 (I-Flow Corp., 1995) and 3 other predicates after a 241-day review. Its family tree reaches back 4 generations to 1990. 3 of the 19 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 13, 2012
- Review
- 241 days
- Class
- Class II
- Product code
- LZH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K904518 (1990). 18 ancestors in all, the oldest K890120 (1989). No later device cites it as a predicate yet. 3 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 3 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 2 generations backK022575 Perfusor Compact with FM SystemB.Braun Medical, Inc. · 2002
- 1 generation backK062699 Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2006
- This deviceK111381 Medi-Sis Syringe Infusion SystemAcacia, Inc. · 2012
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −3 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −2 | K022575 | Perfusor Compact with FM System | B.Braun Medical, Inc. | 2002 | — |
| −1 | K062699 | Perfusor Space Infusion Syringe Pump System | B.Braun Medical, Inc. | 2006 | — |
| 0 (this device) | K111381 | Medi-Sis Syringe Infusion System | Acacia, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 1 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 1 |
| 2003 | 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.
3 devices in this family have a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K953028 | Titan Driver 60CC, 30 Minute Administration SetSummary page 1…IS Syringe Infusion System is substantially equivalent in intended use, principle of operation and technological characteristics to the Medi-SIS Syringe Infusion System (K953028, K<954059, K<9721 73), and is substantially equivalent in intended use with the B. Braun Perfusor Space Infusion Syringe Pump Sys… | 1995 |
| * | K954059 | Titan 20 CC DriverSummary page 1…fusion Pump DEVICE CLASSIFICATION: Class 11 PRODUCT CODE FRN, LZH PREDICATE DEVICES: Medi-SIS Syringe Infusion System (K<953028, K<954059, K972173) B. Braun Perfusor Space Infusion Syringe Pump System (K06… | 1995 |
| * | K972173 | Medi-Sis Syringe Infusion SystemSummary page 1…ump DEVICE CLASSIFICATION: Class 11 PRODUCT CODE FRN, LZH PREDICATE DEVICES: Medi-SIS Syringe Infusion System (K<953028, K<954059, K972173) B. Braun Perfusor Space Infusion Syringe Pump System (K062699) P… | 1997 |
| * | K062699 | Perfusor Space Infusion Syringe Pump SystemSummary page 1…Syringe Infusion System (K<953028, K<954059, K972173) B. Braun Perfusor Space Infusion Syringe Pump System (K062699) Purpose The purpose of this submission is to add the delivery of enteral fluids through clinically accepted routed of administ… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · 3 generations back · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 7 of the 18 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K953028.
How does its category compare?
All LZH devicesLZH Pump, Infusion, Enteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Medi-SIS Syringe Infusion System is indicated for the delivery of enteral fluids through clinically accepted routes of administration.
The Medi-SIS Administration Extension Set is intended for single patient use only.
The Medi-SIS Syringe Driver can be reused up to 5,000 times
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111381: Medi-Sis Syringe Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111381
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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