510(k) · Cleared
ClearedCurlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zevex, Inc. · FRN Pump, Infusion
Cleared on Oct 3, 2024 as substantially equivalent to K232793 (Zevex, Inc., 2024) after a 29-day review. Its family tree reaches back 5 generations to 1996. 5 of the 9 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 3, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K960826 (1996). 8 ancestors in all. No later device cites it as a predicate yet. 5 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK960826 Cadd-Prizm Model 6100 PumpSims Deltec, Inc. · 1996 · Recalled
- 4 generations backK111275 Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication…Smiths Medical Asd, Inc. · 2013 · Recalled (Class I)
- 3 generations backK130394 Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 2013 · Recalled (Class I)
- 2 generations backK170982 CADD®- Solis Ambulatory Infusion Pump with Wireless Communication…Smiths Medical Ads, Inc. · 2017 · Recalled (Class I)
- 1 generation backK232793 Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES)…Zevex, Inc. · 2024
- This deviceK242660 Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES)…Zevex, Inc. · 2024
Class I recalls in this family
- K170982 CADD®- Solis Ambulatory Infusion Pump with…2 generations back · 2017
- K111275 Cadd Solis Vip Ambulatory Infusion Pump and Cadd…2 generations back · 2013
- K130394 Cadd -Solis Ambulatory Infusion Pump, Version 3.03 generations back · 2013
- K072144 Cadd -Solis Ambulatory Infusion Pump and Cadd…3 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960826 | Cadd-Prizm Model 6100 Pump | Sims Deltec, Inc. | 1996 | 1 |
| −4 | K111275 | Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety… | Smiths Medical Asd, Inc. | 2013 | Class I |
| −3 | K130394 | Cadd -Solis Ambulatory Infusion Pump, Version 3.0 | Smiths Medical Asd, Inc. | 2013 | Class I |
| −2 | K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis… | Smiths Medical Ads, Inc. | 2017 | Class I |
| −1 | K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software… | Zevex, Inc. | 2024 | — |
| 0 (this device) | K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software… | Zevex, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 1 |
| 2008 | 2 | 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.
5 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? (1)
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 |
|---|---|---|---|
| * | K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…Summary page 5…Regulatory Class: II Product Code: FPA III. PREDICATE DEVICE CURLIN® 8000 Ambulatory Infusion System with Rx Manager Enterprise Solution Software (K232793) IV. DEVICE BRIEF DESCRIPTION The Curlin 8000 Ambulatory Infusion Pump is a small, compact and light weight in… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 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.
- K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110…Smiths Medical Ads, Inc. · 2017 · 2 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
- K111275Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety SoftwareSmiths Medical Asd, Inc. · 2013 · 2 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
- K130394Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 2013 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- 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
- K040636Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension SetSmiths Medical MD, Inc. · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 6 of the 8 ancestors have a recall of any class; 5 have a Class I recall.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The CURLIN® 8000 ambulatory infusion pump system is indicated for use in home care and clinical settings for the controlled administration of prescribed medical fluids through clinically accepted routes of administration: intravenous, intra-arterial, subcutaneous, epidural, and perineural, and to adult and pediatric patients. The pump is intended to deliver a variety of therapies (drugs and fluids) which have been approved for these routes of…
Read the full statement (151 words)
The CURLIN® 8000 ambulatory infusion pump system is indicated for use in home care and clinical settings for the controlled administration of prescribed medical fluids through clinically accepted routes of administration: intravenous, intra-arterial, subcutaneous, epidural, and perineural, and to adult and pediatric patients. The pump is intended to deliver a variety of therapies (drugs and fluids) which have been approved for these routes of administration. Examples of the therapies, which may be delivered using the CURLIN® 8000 pump, include hydration, parenteral nutrition, anti-infectives, pain management, inotropes, chemotherapy, immune globulin, and biologics. The CURLIN 8000 is not indicated for the delivery of cellular blood products.
RxManager Enterprise Solution Software allows the user to create and manage pump configurations and therapy-based protocols to be used with the Curlin 8000 Ambulatory Infusion Pump.
Curlin Administration Sets are intended to be used with Curlin infusion pumps to deliver medication from a container to a patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242660: Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series 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/K242660
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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