510(k) · Cleared
ClearedReplacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head Door Assembly, P2, Model BX10469
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American I.V. Products, Inc. · FRN Pump, Infusion
Cleared on Oct 9, 2003 as substantially equivalent to K915522 (Baxter Healthcare Corp, 1992) and 1 other predicate after a 31-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Oct 9, 2003
- Review
- 31 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915522 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK915522 Flo-Gard (R) 6201Baxter Healthcare Corp · 1992 · Recalled
- This deviceK032789 Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement…American I.V. Products, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915522 | Flo-Gard (R) 6201 | Baxter Healthcare Corp | 1992 | 6 |
| 0 (this device) | K032789 | Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head… | American I.V. Products, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 |
|---|---|---|---|
| * | K915522 | Flo-Gard (R) 6201Summary page 1…p Head Door Assembly, P2 Predicate Device: These door assemblies are equivalent to the legally marketed door assemblies in the following devices: Baxter Flo-Gardm6201 - K915522 Baxter Flo-Gard@6301 - K915523 Description: AIV's pump door assemblies are replacements for similar doors manufactured by Baxter… | 1992 |
| * | K915523 | Flo-Gard (R) 6301Summary page 1…cate Device: These door assemblies are equivalent to the legally marketed door assemblies in the following devices: Baxter Flo-Gardm6201 - K915522 Baxter Flo-Gard@6301 - K915523 Description: AIV's pump door assemblies are replacements for similar doors manufactured by Baxter Healthcare Corporation for the… | 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?
- 2 of the 2 ancestors have a recall of any class.
- 4 other devices also cite its predicate K915522.
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?
These devices are intended to be used as replacement door assemblies for Baxter Flo-GardB 6201 and Baxter Flo-Gard@6301 volumetric infusion pumps, for use to deliver drug solutions, enteral feedings and blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032789 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032789: Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head Door Assembly, P2, Model BX10469.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032789
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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