510(k) · Cleared
ClearedPump Connectivity Interface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FRN Pump, Infusion
Cleared on Nov 30, 2004 after a 229-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 30, 2004
- Review
- 229 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Alaris Medley System with MMS Named without a submission number | |
| * | — | B. Braun Horizon Outlook with DoseCorn Named without a submission number |
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.
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?
The Pump Connectivity Interface is a computerized wireless patient information and medication management tool that is integrated into an existing hospital network infrastructure and allows communications with external devices, including personal computers (PCs), Personal Digital Assistants (PDAs) or similar display/computing devices, hospital monitoring systems, and Hospital Information Management Systems (HIMS). Communication of data includes infusion…
Read the full statement (194 words)
The Pump Connectivity Interface is a computerized wireless patient information and medication management tool that is integrated into an existing hospital network infrastructure and allows communications with external devices, including personal computers (PCs), Personal Digital Assistants (PDAs) or similar display/computing devices, hospital monitoring systems, and Hospital Information Management Systems (HIMS). Communication of data includes infusion parameters, system configuration, history, events, trending, alarms and status. It is intended for use in professional healthcare environments that use electronic, external infusion devices.
The Pump Connectivity Interface is intended to provide trained healthcare practitioners access to additional information needed to more safely manage infusion therapy via infusion pumps. It enables remote viewing of pump status within the hospital and enables comparisons of pharmacy-entered prescription information to programmed pump settings. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
The Pump Connectivity Interface also enables secondary notification of pump alerts and alarms to remote users via a personal digital assistant (PDA) or similar display/computing device.
The Pump Connectivity Interface is intended for use by trained healthcare practitioners in accordance with the instructions provided in Pump Connectivity Interface labeling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040985 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040985: Pump Connectivity Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040985
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026