510(k) · Cleared
ClearedCompuflo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Milestone Scientific, Inc. · FRN Pump, Infusion
Cleared on Jul 10, 2006 as substantially equivalent to K050107 (Harvard Clinical Technology, 2005) and 2 other predicates after a 202-day review. Its family tree reaches back 3 generations to 1994. 2 of the 17 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Jul 10, 2006
- Review
- 202 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K940147 (1994). 10 ancestors in all, the oldest K890120 (1989). 6 later devices descend from it, 1 citing it directly. 2 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK940147 Auto Syringe AS40A Infusion PumpBaxter Corp. · 1994 · Recalled
- 2 generations backK974332 Variable Pressure Syringe PumpAlaris Medical Systems, Inc. · 1998
- 1 generation backK023264 Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Recalled (Class I)
- This deviceK053554 CompufloMilestone Scientific, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK101194 Navigator Delivery System (or Navigator DS) Model: Nav-010Carticept Medical, Inc. · 2011
- Descendant · 2 generations on · 4 of its ownK112067 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK120830 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2012
- Descendant · 4 generations on · 2 of its ownK122215 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2012
- Descendant · 5 generations on · 1 of its ownK124053 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K101194Navigator Delivery System (or Navigator DS) Model: Nav-010Carticept Medical, Inc. · 2011 · cites it directly5descendants
- K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2011 · 2 generations on4descendants
- K120830Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2012 · 3 generations on3descendants
- K122215Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2012 · 4 generations on2descendants
- K124053Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2013 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940147 | Auto Syringe AS40A Infusion Pump | Baxter Corp. | 1994 | 1 |
| −2 | K974332 | Variable Pressure Syringe Pump | Alaris Medical Systems, Inc. | 1998 | — |
| −1 | K023264 | Medley Syringe Pump Module System, Model 8110 | Alaris Medical Systems, Inc. | 2002 | Class I |
| 0 (this device) | K053554 | Compuflo | Milestone Scientific, Inc. | 2006 | — |
| +1 | K101194 | Navigator Delivery System (or Navigator DS) Model: Nav-010 | Carticept Medical, Inc. | 2011 | — |
| +2 | K112067 | Navigator Delivery System (Navigator DS) | Carticept Medical, Inc. | 2011 | — |
| +3 | K120830 | Navigator Delivery System (Navigator DS) | Carticept Medical, Inc. | 2012 | — |
| +4 | K122215 | Navigator Delivery System (Navigator DS) | Carticept Medical, Inc. | 2012 | — |
| +5 | K124053 | Navigator Delivery System (Navigator DS) | Carticept Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 1 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K050107 | Harvard 2 Syringe Pump, Model 2001-001Summary page 2…al Equivalence The CompuFlo raises no new questions of safety or effectiveness as compared to Harvard Clinical Technology, Inc.'s Harvard 2 Syringe Pump (K050107), Alaris Medical Systems, Inc.'s Medley Syringe Pump Module (K023264), and Medex, Inc.'s Medex 3000 Series Infusion Pump (K040899… | 2005 |
| * | K023264 | Medley Syringe Pump Module System, Model 8110Summary page 1…F.R. § 880.5725 Predicate Devices * Harvard Clinical Technology, Inc.'s Harvard 2 Syringe Pump (KOSO0107) * Alaris Medical Systems, Inc.'s Medley Syringe Pump Module (K023264) * Medex, Inc.'s Medex 3000 Series Infusion Pump (K040899) V,\\lC -924e280001 -2236040 v I… | 2002 |
| * | K040899 | Medex 3000 Series MR Syringe Infusion PumpSummary page 1…nology, Inc.'s Harvard 2 Syringe Pump (KOSO0107) * Alaris Medical Systems, Inc.'s Medley Syringe Pump Module (K023264) * Medex, Inc.'s Medex 3000 Series Infusion Pump (K040899) V,\\lC -924e280001 -2236040 v I CompuFl… | 2004 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101194 | Navigator Delivery System (or Navigator DS) Model: Nav-010 | 2011 | 5 |
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.
- K040899Medex 3000 Series MR Syringe Infusion PumpMedex, Inc. · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 14 Class I recalls
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 5 of the 10 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K101194 (Carticept Medical, Inc., 2011) has gone furthest, with 5 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) | — |
What is it indicated for?
The CompuFlo is intended for use in delivering medication and other fluids in a controlled manner. The CompuFlo is indicated for use in adults for the continuous or intermittent delivery of medications and other fluids through intravenous, intra-arterial, subcutaneous, epidural and enteral routes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053554: Compuflo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053554
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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