510(k) · Cleared
ClearedAvoset Infusion Pump System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eitan Medical, Ltd. · FRN Pump, Infusion
Cleared on Mar 10, 2023 as substantially equivalent to K170982 (Smiths Medical Ads, Inc., 2017) and 1 other predicate after a 466-day review. Its family tree reaches back 8 generations to 1990. 11 of the 31 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 10, 2023
- Review
- 466 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K904518 (1990). 30 ancestors in all. No later device cites it as a predicate yet. 11 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 7 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 6 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 5 generations backK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- 4 generations backK123049 Sapphire Infusion PumpQ Core Medical, Ltd. · 2013
- 3 generations backK141389 Sapphire Infusion PumpQ Core Medical, Ltd. · 2014
- 2 generations backK161667 Sapphire Infusion PumpQ Core Medical, Ltd. · 2017
- 1 generation backK192860 Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · Recalled (Class I)
- This deviceK213744 Avoset Infusion Pump SystemEitan Medical, Ltd. · 2023
Class I recalls in this family
- K192860 Sapphire Infusion Pump, Sapphire administration…direct predicate · 2020
- K170982 CADD®- Solis Ambulatory Infusion Pump with…direct predicate · 2017
- K130394 Cadd -Solis Ambulatory Infusion Pump, Version 3.02 generations back · 2013
- K040636 Cadd Administration Set with Flow Stop…2 generations back · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −7 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −6 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −5 | K042121 | Spectrum and Spectrum with Master Drug Library | Sigma Intl. | 2004 | Class I |
| −4 | K123049 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2013 | — |
| −3 | K141389 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2014 | — |
| −2 | K161667 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2017 | — |
| −1 | K192860 | Sapphire Infusion Pump, Sapphire administration sets | Q Core Medical, Ltd. | 2020 | Class I |
| 0 (this device) | K213744 | Avoset Infusion Pump System | Eitan Medical, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 1 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 2 |
| 2006 | 1 | 0 |
| 2008 | 3 | 1 |
| 2013 | 2 | 2 |
| 2017 | 1 | 1 |
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.
11 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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 |
|---|---|---|---|
| * | K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion…Summary page 4…Administration Sets (21 CFR 880.5440) Class II Predicate Device CADD-Solis system (pump and PC Tool) cleared under K170982 For Infusion pump Predicate Device for (K192860) Sapphire administration sets Administration sets Date of Prepa… | 2017 |
| * | K192860 | Sapphire Infusion Pump, Sapphire administration setsSummary page 4…Class II Predicate Device CADD-Solis system (pump and PC Tool) cleared under K170982 For Infusion pump Predicate Device for (K192860) Sapphire administration sets Administration sets Date of Preparation 8 March 2023 Device Description The Avoset… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (11 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.
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110…Smiths Medical Ads, Inc. · 2017 · Direct predicate · ◆ in the 2017 ancestors bar of FIG. 15 Class I recalls
- K130394Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 2013 · 2 generations back · ◆ in the 2013 ancestors bar of FIG. 11 Class I recall
- K040636Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension SetSmiths Medical MD, Inc. · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K111275Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety SoftwareSmiths Medical Asd, Inc. · 2013 · 3 generations back · ◆ in the 2013 ancestors bar of FIG. 15 Class I recalls
- K072144Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - AdministratorSmiths Medical MD, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 12 Class I recalls
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · 3 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet…Hospira, Inc. · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 14 Class I recalls
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 5 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 19 of the 30 ancestors have a recall of any class; 11 have a Class I recall.
- 1 other device also cites its predicate K170982.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
Intended use: The Avoset Infusion Pump is a single-channel, volumetric infusion pump. Medication is delivered at continuous rate, and/or with an intermittent bolus, and/or with a patient bolus and/or with taper. Indication of use: Routes: Parenteral (intra-arterial, intra-venous, subcutaneous, perineural, epidural) and enteral infusions Fluids: IV medication (including fluids), Total Parenteral Nutrition (TPN), enteral medication and nutrition, lipids…
Read the full statement (198 words)
Intended use:
The Avoset Infusion Pump is a single-channel, volumetric infusion pump. Medication is delivered at continuous rate,
and/or with an intermittent bolus, and/or with a patient bolus and/or with taper.
Indication of use:
Routes: Parenteral (intra-arterial, intra-venous, subcutaneous, perineural, epidural)
and enteral infusions
Fluids: IV medication (including fluids), Total Parenteral Nutrition (TPN), enteral medication and nutrition, lipids,
epidural medication.
Program Types (specific uses): The pump delivers in one of four program types: a continuous rate of infusion, and/or an
intermittent bolus, and/or with patient-controlled intermittent doses, and/or with tapering.
Patient Population: Pediatric: infants, children, and adolescents and adult patients.
Intended Environments. Intended to be used in clinical environment and ambulatory environment including, home, plane
and ground transportation.
Users: licensed health care professional and lay users
The dedicated Administration Sets for the Avoset Infusion Pump are intended for single-patient use and single-use only.
Set configurations are: (i) Enteral; (ii) Epidural and (iii) General purpose for the balance of the routes: intra-arterial, intra-
venous, subcutaneous, perineural.
The Avoset Programming Tool is intended to be used with a computer to create a treatment-based protocol that is loaded onto the pump. The programming tool is intended for use by professional users.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213744 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213744: Avoset Infusion Pump System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213744
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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