510(k) · Cleared
Recalled · 2011Flo-Gard (R) 6201
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 Feb 28, 1992 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 22 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled 6 times.
- Decided
- Feb 28, 1992
- Review
- 80 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 6
- Predicates
- 0
21 later devices descend from it, 5 citing it directly. 6 of the 22 devices in this family, counting this one, have a Class I recall.
- This deviceK915522 Flo-Gard (R) 6201Baxter Healthcare Corp · 1992
- Descendant · cites it directly · 16 of its ownK972678 Millennium CRT Infusion Pump and Millennium CRT Infusion Pump…Mcgaw, Inc. · 1997
- Descendant · 2 generations on · 15 of its ownK062700 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Recalled (Class I)
- Descendant · 3 generations on · 6 of its ownK140838 IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014
- Descendant · 3 generations on · 4 of its ownK083689 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · Recalled (Class I)
- Descendant · 4 generations on · 3 of its ownK170595 IV Administration SetsB.Braun Medical, Inc. · 2017 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 21 · See all- K972678Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration SetsMcgaw, Inc. · 1997 · cites it directly16descendants
- K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · 2 generations on15descendants
- K140838IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014 · 3 generations on6descendants
- K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · 3 generations on4descendants
- K170595IV Administration SetsB.Braun Medical, Inc. · 2017 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915522 | Flo-Gard (R) 6201 | Baxter Healthcare Corp | 1992 | — |
| +1 | K972678 | Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration… | Mcgaw, Inc. | 1997 | — |
| +2 | K062700 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | 2006 | Class I |
| +3 | K140838 | IV Administration Set with Hand Pump | B.Braun Medical, Inc. | 2014 | — |
| +3 | K083689 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | 2009 | Class I |
| +4 | K170595 | IV Administration Sets | B.Braun Medical, Inc. | 2017 | 19 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 1 |
| 2007 | 1 | 0 |
| 2009 | 1 | 1 |
| 2013 | 1 | 1 |
| 2014 | 2 | 1 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 3 | 1 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (21)
See all 215 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972678 | Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration Sets | 1997 | 16 |
| K070529 | Aff (Mark I) Volumetric Infusion Pump | 2007 | 0 |
| K032789 | Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head Door… | 2003 | 0 |
| K993524 | Advantis Asc Infusion Pump and Administration Sets | 2000 | 0 |
| K961703 | Colleague 2 Volumetric Infusion Pump (Dual Channel)/Colleague 3 Volumetric Infusion Pump… | 1996 | 0 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2011 | Not classified | Z-2122-2011 | Employee error | Pumps submitted for service may not have been properly serviced before being returned to the customer. |
| Nov 17, 2010 | Not classified | Z-0933-2011 | Process control | The FloGard Infusion Pump was released from service without having the Current Leakage test performed. This could lead to the patient/user to receive an electrical shock. |
| Jun 21, 2007 | Not classified | Z-1111-2007 | Other | Falsified Repair/Test and Inspection records: Pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer. |
| Nov 27, 2006 | Not classified | Z-0632-2007 | Other | There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretrol or blood filter. |
| May 3, 2005 | Not classified | Z-1552-05 | Other | The mounting screws of the pole clamp may come loose, allowing the pole clamp assembly to detach from the rear pump housing, if they are not maintained on at least an annual basis. |
| May 3, 2005 | Not classified | Z-1553-05 | Other | The mounting screws of the pole clamp may come loose, allowing the pole clamp assembly to detach from the rear pump housing, if they are not maintained on at least an annual basis. |
The 5 latest of 6 recalls; the web page lists all.
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.
- K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K142036Infusomat Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
- K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K142596Infusomat Space Volumetric Infusion PumpB.Braun Medical, Inc. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K972678 (Mcgaw, Inc., 1997) has gone furthest, with 16 descendants of its own.
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) | — |
https://510kreport.com/device/K915522 · printed Nov 3, 2026
Cite this page
510(k) Report. “K915522: Flo-Gard (R) 6201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K915522
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026