510(k) · Cleared
ClearedElite Biomedical Solutions Dose Request Cord
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elite Biomedical Solutions · MRZ Accessories, Pump, Infusion
Cleared on Apr 29, 2022 as substantially equivalent to K120209 (American I.V. Products, Inc., 2012) after a 51-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Apr 29, 2022
- Review
- 51 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K926385 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK926385 Bard Apii PumpC.R. Bard, Inc. · 1994 · Recalled
- 3 generations backK993387 Ipump Pain Management System, Model 2L3107KBaxter Healthcare Corp · 1999 · Recalled
- 2 generations backK052973 Ipump Pain Management System, Model 2L3107, 2L3107KBaxter Healthcare Corp · 2007
- 1 generation backK120209 Patient Controlled Analgesia (Pca) Button CableAmerican I.V. Products, Inc. · 2012
- This deviceK220695 Elite Biomedical Solutions Dose Request CordElite Biomedical Solutions · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K926385 | Bard Apii Pump | C.R. Bard, Inc. | 1994 | 2 |
| −3 | K993387 | Ipump Pain Management System, Model 2L3107K | Baxter Healthcare Corp | 1999 | 3 |
| −2 | K052973 | Ipump Pain Management System, Model 2L3107, 2L3107K | Baxter Healthcare Corp | 2007 | — |
| −1 | K120209 | Patient Controlled Analgesia (Pca) Button Cable | American I.V. Products, Inc. | 2012 | — |
| 0 (this device) | K220695 | Elite Biomedical Solutions Dose Request Cord | Elite Biomedical Solutions | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 MRZ? 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 MRZ device
- #1 K193654 BlueStar Rxscore 7.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K120209 | Patient Controlled Analgesia (Pca) Button CableSummary page 4…MRZ III. Predicate Device Device Name: Patient Pendant Bolus Cable Manufacturer: American IV Products, Inc. 510(k): K120209 IV. Device Description Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris PCA Pump Model 8120… | 2012 |
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?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MRZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MRZ
96in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRZ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRZ
35in 2025
MAUDE reports naming product code MRZ, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 96 | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 117 |
| 2016 | 2 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 1 | — | 1 | 46 |
| 2019 | 1 | — | 5 | 36 |
| 2020 | 2 | — | 0 | 44 |
| 2021 | 1 | — | 0 | 61 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Elite Biomedical Solutions Dose Request Cord is an accessory for a syringe pump and may be used in the same
environment as the corresponding pump. The healthcare worker connects the device to the pump. The patient uses the
switch on the cable to signal the syringe pump to deliver medication consistent with the parameters entered into the pump
by the healthcare worker. The Elite Biomedical Solutions Dose Request Cord is a non-sterile, reusable device intended for
multi-patient use in adult and adolescent (over 12 years of age) populations.
Elite Biomedical Part #: 10013795 EBS
Corresponding Pump: BD Alaris PCA Pump Model 8120
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220695 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220695: Elite Biomedical Solutions Dose Request Cord.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220695
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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