510(k) · Cleared
ClearedBeeline Motiv, Propolis, Pca
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mckinley, Inc. · FRN Pump, Infusion
Cleared on Nov 8, 2004 as substantially equivalent to K032642 (Mckinley, Inc., 2003) and 4 other predicates after an 83-day review. Its family tree reaches back 7 generations to 1990. 1 of the 31 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Nov 8, 2004
- Review
- 83 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K896422 (1990). 23 ancestors in all, the oldest K884505 (1989). 7 later devices descend from it, 1 citing it directly. 1 of the 31 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 6 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 5 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 4 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 3 generations backK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
- 2 generations backK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
- 1 generation backK032642 Beeline SystemMckinley, Inc. · 2003
- This deviceK042228 Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004
- Descendant · cites it directly · 6 of its ownK050770 Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005
- Descendant · 2 generations on · 5 of its ownK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
- Descendant · 2 generations on · 4 of its ownK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
- Descendant · 4 generations on · 0 of its ownK250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K081905 Accuflow and Accuflux Elastomeric Infusion Pump2 generations on · 2008
Most influential descendants
Showing 5 of 7 · See all- K050770Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005 · cites it directly6descendants
- K052451MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005 · 2 generations on5descendants
- K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 2 generations on4descendants
- K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016 · 3 generations on3descendants
- K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −6 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −5 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −4 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −3 | K020862 | I-Flow Elastomeric Pump | I-Flow Corp. | 2002 | 1 |
| −2 | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit | Mckinley Infuser | 2002 | — |
| −1 | K032642 | Beeline System | Mckinley, Inc. | 2003 | — |
| 0 (this device) | K042228 | Beeline Motiv, Propolis, Pca | Mckinley, Inc. | 2004 | — |
| +1 | K050770 | Modification to Accufuser, Accufuser Plus Standard Procedure Kit | Mckinley Medical, LLC | 2005 | — |
| +2 | K052451 | MPS Acacia Medflo Elastomeric Pump | Mps Acacia | 2005 | — |
| +2 | K081905 | Accuflow and Accuflux Elastomeric Infusion Pump | Westmed, Inc. | 2008 | Class I |
| +3 | K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte., Ltd. | 2016 | — |
| +4 | K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2008 | 1 | 1 |
| 2016 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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.
1 device in this family has 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? (5)
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 |
|---|---|---|---|
| * | K032642 | Beeline SystemSummary page 1…pital and Personal Use Device Regulation Number: Class II, 880.5725 Procode: FRN Original and previously K990461 and K032642 cleared 510(k)s: Summary of Safety and Effectiveness for the Beeline System Modifications to the existing device c… | 2003 |
| * | K033039 | Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsSummary page 1…inley Beeline system (K032642). Supporting predicate devices also demonstrating substantial equivalence is McKinley's Accufuser, Accufuser Plus & standard procedure kit (K03 3039), the I-Flow Elastomeric Pump (K040337), the Baxter Colleague Volumetric Pump (KO10566), and the SIMS Deltec CADD-Prizm® Model 61… | 2003 |
| * | K040337 | I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump)Summary page 1…ng predicate devices also demonstrating substantial equivalence is McKinley's Accufuser, Accufuser Plus & standard procedure kit (K03 3039), the I-Flow Elastomeric Pump (K040337), the Baxter Colleague Volumetric Pump (KO10566), and the SIMS Deltec CADD-Prizm® Model 6101 Ambulatory Infusion System (K000842)… | 2004 |
| * | K010566 | Colleague Volumetric Infusion Pump | 2001 |
| * | K000842 | Cadd-Prizm PCS II Model 6101 Ambulatory Infusion SystemSummary page 1…(K03 3039), the I-Flow Elastomeric Pump (K040337), the Baxter Colleague Volumetric Pump (KO10566), and the SIMS Deltec CADD-Prizm® Model 6101 Ambulatory Infusion System (K000842). The Beeline system is intended for use as follows: I. The Beeline system is intended for continuous and/or intermittent infu… | 2000 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050770 | Modification to Accufuser, Accufuser Plus Standard Procedure Kit | 2005 | 6 |
Has anything in its family been recalled? (1 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.
- K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 6 of the 23 ancestors have a recall of any class.
- Of its descendants, K050770 (Mckinley Medical, LLC, 2005) has gone furthest, with 6 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?
1. The Beeline system is intended for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management. The Beeline system is indicated for intravenous, intra-arterial, enteral, subcutaneous, percutaneous and epidural infusion of medications or fluids requiring continuous and/or intermittent delivery at controlled infusion rates. The Beeline system is suitable for use as an…
Read the full statement (164 words)
1. The Beeline system is intended for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management. The Beeline system is indicated for intravenous, intra-arterial, enteral, subcutaneous, percutaneous and epidural infusion of medications or fluids requiring continuous and/or intermittent delivery at controlled infusion rates. The Beeline system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment, and alternative care sites.
2. The Beeline system is intended to provide continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. The Beeline system is also intended for patient-controlled infusion using the integrated bolus device.
3. The Beeline system is intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042228: Beeline Motiv, Propolis, Pca.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042228
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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