510(k) · Cleared
ClearedAlaris PC Unit Module 8000 with Software Correction
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 303, Inc. · FRN Pump, Infusion
Cleared on Mar 26, 2012 as substantially equivalent to K091308 (Cardinal Health 303,Inc., 2009) after a 395-day review. Its family tree reaches back 3 generations to 1995. 2 of the 4 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 26, 2012
- Review
- 395 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950419 (1995). No later device cites it as a predicate yet. 2 of the 4 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK950419 The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · Recalled (Class I)
- 2 generations backK051641 Alaris System PC Unit, Model 8001Cardinal Health, Alaris Products · 2005 · Recalled (Class I)
- 1 generation backK091308 Alaris PC Unit, Models 8000 and 8015Cardinal Health 303,Inc. · 2009
- This deviceK110535 Alaris PC Unit Module 8000 with Software CorrectionCarefusion 303, Inc. · 2012
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950419 | The Imed Orion Infusion Pump and Administration Sets | Imed Corp. | 1995 | Class I |
| −2 | K051641 | Alaris System PC Unit, Model 8001 | Cardinal Health, Alaris Products | 2005 | Class I |
| −1 | K091308 | Alaris PC Unit, Models 8000 and 8015 | Cardinal Health 303,Inc. | 2009 | — |
| 0 (this device) | K110535 | Alaris PC Unit Module 8000 with Software Correction | Carefusion 303, Inc. | 2012 | — |
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.
2 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 |
|---|---|---|---|
| * | K091308 | Alaris PC Unit, Models 8000 and 8015 | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
- K051641Alaris System PC Unit, Model 8001Cardinal Health, Alaris Products · 2005 · 2 generations back · ◆ on the line of descent in FIG. 110 Class I recalls
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · 3 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 3 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K091308.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Alaris® PC Unit is the main user interface unit and power supply of the Alaris® System, a modular system to be used with Alaris® System modules (aka Medley™ System modules) intended for use in today's growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Alaris® System module is specified in its respective submission.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110535: Alaris PC Unit Module 8000 with Software Correction.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110535
Report an extraction error
Are you the manufacturer?
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