510(k) · Cleared
ClearedDelphi Infusion Pump/ Delphi Administration Set Model IV-01000/ Model IV-02XXXX (Where X IS Any Number Between 0-9)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Delphi Medical Systems · FRN Pump, Infusion
Cleared on Dec 9, 2009 as substantially equivalent to K953896 (Imed Corp., 1996) and 1 other predicate after a 44-day review. Its family tree reaches back 4 generations to 1990. 3 of the 10 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 9, 2009
- Review
- 44 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K904518 (1990). 9 ancestors in all. No later device cites it as a predicate yet. 3 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 3 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 2 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 1 generation backK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- This deviceK093332 Delphi Infusion Pump/ Delphi Administration Set Model IV-01000/…Delphi Medical Systems · 2009
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −3 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −2 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −1 | K042121 | Spectrum and Spectrum with Master Drug Library | Sigma Intl. | 2004 | Class I |
| 0 (this device) | K093332 | Delphi Infusion Pump/ Delphi Administration Set Model IV-01000/ Model… | Delphi Medical Systems | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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.
3 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? (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 |
|---|---|---|---|
| * | K953896 | The Imed Ambulatory Infusion Pump, Administration SetsSummary page 1…40 / 21 CFR 880.5440 Predicate Device: Delphi Medical Systems, IWantage Infusion Pump, 51 0(k) # K953896* Sigma International, Spectrum and Spectrum… | 1996 |
| * | K042121 | Spectrum and Spectrum with Master Drug LibrarySummary page 1…* Sigma International, Spectrum and Spectrum with Master Drug Library, 51 0(k) #K042121 Indications For Use: The Delphi Infusion Pump is intended for use in the controlled delivery of epidural and IV solutions.… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 6 of the 9 ancestors have a recall of any class; 3 have 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. 2009, 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 Delphi Infusion Pump is intended for use in the controlled delivery of epidural and IV solutions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093332: Delphi Infusion Pump/ Delphi Administration Set Model IV-01000/ Model IV-02XXXX (Where X IS Any Number Between 0-9).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093332
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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