510(k) · Cleared
ClearedSmartlank Wireless, Model 001970
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mrl, A Welch Allyn Company · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on May 25, 2004 after a 187-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 25, 2004
- Review
- 187 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, 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 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
The SmartLink Wireless system's primary function is to transfer 12 lead ECG and other vital signs data from a Welch Allyn PIC50 Defibrillator/Monitor at a remote location to a personal computer station, and to display the data on the computer's monitor. The data is intended to be used by Emergency Room staff for the purpose of patient assessment prior to arrival of the patient at the Emergency Room, in order to reduce the delay in treating the patient…
Read the full statement (220 words)
The SmartLink Wireless system's primary function is to transfer 12 lead ECG and other vital signs data from a Welch Allyn PIC50 Defibrillator/Monitor at a remote location to a personal computer station, and to display the data on the computer's monitor. The data is intended to be used by Emergency Room staff for the purpose of patient assessment prior to arrival of the patient at the Emergency Room, in order to reduce the delay in treating the patient upon arrival.
The SmartLink Wireless system can be used to:
* Provide users of Welch Allyn PIC 50 products in the field the capability of transmitting patient vitals using wireless technology to a remote location. At the remote location the information will be used for diagnostic purposes by trained medical personnel. Patient's vitals may include 12 lead data, IBP, NIBP, ETCO 2, Respiratory rate, Heart rate, Temperature, SPO2, and optional single lead ECG snapshot.
* Send automatic pager notification when a new patient record is received at the personal computer station.
* Forward the patient data to any number of e-mail address at remote computers or personal digital assistants.
The SmartLink Wireless system is not intended to be used as a primary alarm source. Patient information received by the SmartLink Wireless system should not be examined for the purpose of generating alarms.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033642 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033642: Smartlank Wireless, Model 001970.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033642
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026