510(k) · Cleared
ClearedPatient Controlled Analgesia (Pca) Button Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American I.V. Products, Inc. · MRZ Accessories, Pump, Infusion
Cleared on Apr 12, 2012 as substantially equivalent to K052973 (Baxter Healthcare Corp, 2007) and 2 other predicates after a 79-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Apr 12, 2012
- Review
- 79 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K926385 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK926385 Bard Apii PumpC.R. Bard, Inc. · 1994 · Recalled
- 2 generations backK993387 Ipump Pain Management System, Model 2L3107KBaxter Healthcare Corp · 1999 · Recalled
- 1 generation backK052973 Ipump Pain Management System, Model 2L3107, 2L3107KBaxter Healthcare Corp · 2007
- This deviceK120209 Patient Controlled Analgesia (Pca) Button CableAmerican I.V. Products, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK220695 Elite Biomedical Solutions Dose Request CordElite Biomedical Solutions · 2022
Most influential descendants
Showing 1 of 1 · See all- K220695Elite Biomedical Solutions Dose Request CordElite Biomedical Solutions · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K926385 | Bard Apii Pump | C.R. Bard, Inc. | 1994 | 2 |
| −2 | K993387 | Ipump Pain Management System, Model 2L3107K | Baxter Healthcare Corp | 1999 | 3 |
| −1 | K052973 | Ipump Pain Management System, Model 2L3107, 2L3107K | Baxter Healthcare Corp | 2007 | — |
| 0 (this device) | K120209 | Patient Controlled Analgesia (Pca) Button Cable | American I.V. Products, Inc. | 2012 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K052973 | Ipump Pain Management System, Model 2L3107, 2L3107KSummary page 3…hese ANV devices are Substantially Equivalent to the accessory available with the following legally marketed devices: BAXTER HEALTHCARE CORP. K052973, K993387 ABBOTT LABORATORIES K022203 MASTER COPY Au,… | 2007 |
| * | K993387 | Ipump Pain Management System, Model 2L3107KSummary page 3…devices are Substantially Equivalent to the accessory available with the following legally marketed devices: BAXTER HEALTHCARE CORP. K052973, K993387 ABBOTT LABORATORIES K022203 MASTER COPY Au,… | 1999 |
| * | K022203 | Abbott Lifecare Pca 3 Infuser, Model 12384Summary page 3…ailable with the following legally marketed devices: BAXTER HEALTHCARE CORP. K052973, K993387 ABBOTT LABORATORIES K022203 MASTER COPY Au, CONFIDENTIALSetoA… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220695 | Elite Biomedical Solutions Dose Request Cord | 2022 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K220695 (Elite Biomedical Solutions, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
This device is an accessory for a syringe or infusion pump. The healthcare worker connects the device to the corresponding 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120209 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120209: Patient Controlled Analgesia (Pca) Button Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120209
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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