510(k) · Cleared
Recalled · Class II · 2017FFR Link, FFR Signal Processing Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Mar 24, 2017 as substantially equivalent to K151613 (Boston Scientific Corporation, 2015) after a 60-day review. Its family tree reaches back 7 generations to 2001. It has been recalled once.
- Decided
- Mar 24, 2017
- Review
- 60 days
- Class
- Class II
- Product code
- DRG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K003122 (2001). 18 ancestors in all, the oldest K921750 (1992). No later device cites it as a predicate yet.
- Root · 7 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 6 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 5 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 4 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 3 generations backK042628 Modification to: Radianalyzer, Model 12711Radi Medical Systems AB · 2005
- 2 generations backK092105 Radianalyzer XpressRadi Medical Systems AB · 2009
- 1 generation backK151613 iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation · 2015
- This deviceK170204 FFR Link, FFR Signal Processing ModuleBoston Scientific Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −6 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −5 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −4 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −3 | K042628 | Modification to: Radianalyzer, Model 12711 | Radi Medical Systems AB | 2005 | — |
| −2 | K092105 | Radianalyzer Xpress | Radi Medical Systems AB | 2009 | — |
| −1 | K151613 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2015 | — |
| 0 (this device) | K170204 | FFR Link, FFR Signal Processing Module | Boston Scientific Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 2 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 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 |
|---|---|---|---|
| * | K151613 | iLab Polaris Multi-Modality Guidance SystemSummary page 4…ass: Class II Product Code: DRG - transmitters and receivers, physiological signal, radiofrequency III. PREDICATE DEVICE iLab Polaris Multi-Modality Guidance System - K151613 IV. REFERENCE DEVICE AO USB Receiver, Wi-Box, Wi-Box PSU Kit, Wi-Box Xpress Cable, PW USB Receiver - K111854 V. DEVICE DESCRIP… | 2015 |
| † | K111854 | AO Usb Receiver, WI-Box, WI-Box Psu Kit, WI-Box Xpress Cable, PW Usb Receiver | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2017 | Class II | Z-3132-2017 | Unknown/Undetermined by firm | The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 18 ancestors have a recall of any class.
- 1 other device also cites its predicate K151613.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The FFR Link ™ is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab™ POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170204: FFR Link, FFR Signal Processing Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170204
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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