510(k) · Cleared
ClearedAbc Syringe Infusion Pump, Model 4100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elixir Corporation · FRN Pump, Infusion
Cleared on Oct 23, 2008 as substantially equivalent to K982640 (Medex, Inc., 1999) and 4 other predicates after a 405-day review. Its family tree reaches back 2 generations to 1989. 1 of the 7 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 23, 2008
- Review
- 405 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K890120 (1989). 6 ancestors in all. No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK890120 Syringe Infusion PumpMedfusion, Inc. · 1989
- 1 generation backK982640 Medex 3000 Series Syringe Infusion PumpMedex, Inc. · 1999 · Recalled
- This deviceK072603 Abc Syringe Infusion Pump, Model 4100Elixir Corporation · 2008
Class I recalls in this family
- K040899 Medex 3000 Series MR Syringe Infusion Pumpdirect predicate · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890120 | Syringe Infusion Pump | Medfusion, Inc. | 1989 | — |
| −1 | K982640 | Medex 3000 Series Syringe Infusion Pump | Medex, Inc. | 1999 | 1 |
| 0 (this device) | K072603 | Abc Syringe Infusion Pump, Model 4100 | Elixir Corporation | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2004 | 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.
1 device in this family has 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? (5)
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 |
|---|---|---|---|
| * | K982640 | Medex 3000 Series Syringe Infusion PumpSummary page 1…Product Code: FRN SUBSTANTIAL EQUIVALENCE The ABC Syringe Infusion Pump Model 4100 is substantially equivalent to the Medex (Medfusion) 3000 series (K982640 and K040899) and 2000 series (K890120, K091755, and K955231) syringe infusion pumps.… | 1999 |
| * | K040899 | Medex 3000 Series MR Syringe Infusion PumpSummary page 1…de: FRN SUBSTANTIAL EQUIVALENCE The ABC Syringe Infusion Pump Model 4100 is substantially equivalent to the Medex (Medfusion) 3000 series (K982640 and K040899) and 2000 series (K890120, K091755, and K955231) syringe infusion pumps.… | 2004 |
| * | K890120 | Syringe Infusion PumpSummary page 1…SUBSTANTIAL EQUIVALENCE The ABC Syringe Infusion Pump Model 4100 is substantially equivalent to the Medex (Medfusion) 3000 series (K982640 and K040899) and 2000 series (K890120, K091755, and K955231) syringe infusion pumps.… | 1989 |
| * | K901755 | Model 3001 Syringe Infusion Pump Our reading of the summary gave K091755, which is not a number in FDA’s lists. Corrected to the only number with two digits swapped in this product code whose FDA name shares the summary’s words. | 1990 |
| * | K955231 | Medfusion Model 2001 Syringe Infusion PumpSummary page 1…E The ABC Syringe Infusion Pump Model 4100 is substantially equivalent to the Medex (Medfusion) 3000 series (K982640 and K040899) and 2000 series (K890120, K091755, and K955231) syringe infusion pumps. 5-1… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K040899Medex 3000 Series MR Syringe Infusion PumpMedex, Inc. · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- 3 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K982640.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
In any area such as neonatal and pediatric intensive care, anesthesia, adult critical care or any other area where the pump use can be monitored or supervised by a trained healthcare professional where the precise administration of fluids including drugs, antibiotics, lipids, blood, blood products, enteral solutions, or other therapeutic solutions is required
Delivery routes include: Intravenous, arterial, epidural, spinal, enteral, and subcutaneous.
Delivery modes include: Continuous, volume/time, mass, body weight, and bolus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072603: Abc Syringe Infusion Pump, Model 4100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072603
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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