510(k) · Cleared
ClearedAbbott Data Port PC, Model 12181
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · FRN Pump, Infusion
Cleared on Jan 29, 2004 as substantially equivalent to K024084 (Abbott Laboratories, 2002) and 3 other predicates after a 9-day review. Its family tree reaches back 1 generation to 1999. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 29, 2004
- Review
- 9 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K982159 (1999). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK982159 Abbott Plum a+ Infusion PumpAbbott Laboratories · 1999 · Recalled
- This deviceK040114 Abbott Data Port PC, Model 12181Abbott Laboratories · 2004
Class I recalls in this family
- K011442 Abbott Plum a+Infusion Pump, Model 11971direct predicate · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982159 | Abbott Plum a+ Infusion Pump | Abbott Laboratories | 1999 | 11 |
| 0 (this device) | K040114 | Abbott Data Port PC, Model 12181 | Abbott Laboratories | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 1 |
| 2002 | 2 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K024084 | Abbott Plum a+ Infusion Pump, Model 12391Summary page 3…# Product Name Clearance Date K024084 Abbott Plum A+ Infusion Pump 12/31/02 K021350 Abbott Plum A+3 Multichannel Inf… | 2002 |
| * | K021350 | Abbott Plum a+3 Multichannel Infusion Pump, Model 12348Summary page 3…Date K024084 Abbott Plum A+ Infusion Pump 12/31/02 K021350 Abbott Plum A+3 Multichannel Infusion Pump 05/14/02 K011442 Abbott Plum A+ Infusion Pump… | 2002 |
| * | K011442 | Abbott Plum a+Infusion Pump, Model 11971Summary page 3…Abbott Plum A+ Infusion Pump 12/31/02 K021350 Abbott Plum A+3 Multichannel Infusion Pump 05/14/02 K011442 Abbott Plum A+ Infusion Pump 06/05/01 K982159 Abbott Plum A+ Infusion Pump… | 2001 |
| * | K982159 | Abbott Plum a+ Infusion PumpSummary page 3…Abbott Plum A+3 Multichannel Infusion Pump 05/14/02 K011442 Abbott Plum A+ Infusion Pump 06/05/01 K982159 Abbott Plum A+ Infusion Pump 01/12/99 12. Comparison to Legally Marketed Device(s)… | 1999 |
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.
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- 3 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K024084.
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 device is used in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040114: Abbott Data Port PC, Model 12181.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040114
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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