Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MXD — Predicate Candidate Screening
33 FDA 510(k) clearances under this product code; the 50 most recent screened below.
67 daysmedian FDA review time
172 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261074 | BIOMONITOR IV (471155) | Biotronik, Inc. | 2026-05-01 | 30 | 0 |
| K253516 | Assert-IQ (DM5100) | ABBOTT MEDICAL | 2025-12-18 | 36 | 0 |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); | Abbott | 2025-09-17 | 149 | 0 |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Inse | Boston Scientific Corporation | 2025-09-12 | 28 | 0 |
| K240693 | LINQ II™ Insertable Cardiac Monitor (ICM) | Medtronic, Inc. | 2024-03-28 | 15 | 0 |
| K233562 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2023-12-06 | 30 | 1 |
| K233320 | LINQ II™ Insertable Cardiac Monitor (LNQ22) | Medtronic, Inc. | 2023-10-31 | 32 | 1 |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corp | 2023-08-19 | 103 | 3 |
| K230375 | BIOMONITOR IV | Biotronik, Inc. | 2023-05-19 | 95 | 0 |
| K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ | Medtronic, Inc. | 2023-04-26 | 57 | 1 |
| K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable C | Medtronic, Inc. | 2023-04-05 | 121 | 0 |
| K221962 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2022-08-25 | 51 | 1 |
| K221856 | BIOMONITOR IIIm, BIOMONITOR III | Biotronik, Inc. | 2022-07-27 | 30 | 0 |
| K212008 | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | 2021-07-22 | 24 | 0 |
| K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classificat | Medtronic, Inc. | 2021-06-11 | 112 | 0 |
| K211304 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2021-05-28 | 29 | 1 |
| K210608 | LUX-Dx Insertable Cardiac Monitor | Boston Scientific Corporation | 2021-05-25 | 85 | 0 |
| K201865 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | 2020-12-08 | 155 | 0 |
| K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Dev | Medtronic, Inc. | 2020-07-03 | 99 | 2 |
| K193473 | LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile App | Boston Scientific Corporation | 2020-06-26 | 193 | 0 |
| K200444 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | 2020-04-23 | 59 | 0 |
| K190548 | BIOMONITOR III, Remote Assistant III | Biotronik, Inc. | 2019-07-05 | 122 | 0 |
| K171514 | BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + | Biotronik, Inc. | 2017-06-29 | 36 | 0 |
| K170628 | BioMonitor 2-AF, BioMonitor 2-S | Biotronik, Inc. | 2017-03-31 | 29 | 0 |
| K162855 | Reveal LINQ | Medtronic, Inc. | 2017-02-23 | 134 | 0 |
| K163460 | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | 2017-02-14 | 67 | 0 |
| K160809 | Reveal LINQ | Medtronic, Inc. | 2016-05-26 | 63 | 0 |
| K160689 | Reveal LINQ | Medtronic, Inc. | 2016-04-22 | 42 | 0 |
| K152995 | BioMonitor 2-AF, BioMonitor 2-S | Biotronik, Inc. | 2016-04-11 | 181 | 0 |
| K150614 | Reveal LINQ | Medtronic, Inc. | 2015-08-06 | 149 | 0 |
| K143503 | BioMonitor | Biotronik, Inc. | 2015-03-19 | 99 | 0 |
| K132960 | BIOMONITOR | Biotronik, Inc. | 2014-06-06 | 259 | 0 |
| K132649 | REVEAL LINQ INSERTABLE CARDIAC MONITOR | Medtronic, Inc. | 2014-02-14 | 172 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda