510(k) · Cleared
ClearedSabratek 4040 Infusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sabratek Corp. · FRN Pump, Infusion
Cleared on Feb 24, 1999 as substantially equivalent to K941984 (Sabratek Corp., 1994) and 1 other predicate after a 363-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Feb 24, 1999
- Review
- 363 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914589 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK914589 Sabratek 3030 Infusion PumpSabratek Corp. · 1992
- This deviceK980751 Sabratek 4040 Infusion PumpSabratek Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914589 | Sabratek 3030 Infusion Pump | Sabratek Corp. | 1992 | — |
| 0 (this device) | K980751 | Sabratek 4040 Infusion Pump | Sabratek Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 FRN? 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 |
|---|---|---|---|
| * | K941984 | Sabratek 6060 Homerun Volumetric Infusion PumpSummary page 1…licable performance standards Have been issued under Section 514 of The Food, Drug and Cosmetic Act. Predicate Device: Sabratek 6060 HOMERUN® Volumetric Infusion Pump, K941984 and Sabratek 3030 Infusion Pump, K914581. ELEMENT OF SABRTATEK 4040 PUMP | SABRATEK 6060 PUMP | SABRATEK 3030 PUMP COMPARISON S1… | 1994 |
| * | K914589 | Sabratek 3030 Infusion Pump Our OCR of the scanned summary read K914581, FDA’s number for Heart Technology Wireclip (Heart Technology, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Sabratek 3030 Infusion Pump”. | 1992 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K941984.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Provide controlled delivery of fluids, blood and blood products and can be used in enteral, epidural, subcutancous, arterial and intravenous applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980751: Sabratek 4040 Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980751
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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