FDA product code · Cardiovascular
Pacemaker/Icd/Crt Non-Implanted Components
0 FDA decisions since 2011. 11 recalls name this code, 0 of them Class I.
Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OSR at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · OSR
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OSR
Too few OSR 510(k)s in any year since 2007 to give a median.
Recalls per year · OSR
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OSR
8,588in 2025
MAUDE reports naming product code OSR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 8 | — | 0 | 8 |
| 2015 | 8 | — | 0 | 46 |
| 2016 | 3 | — | 0 | 29 |
| 2017 | 1 | — | 1 | 40 |
| 2018 | 0 | — | 2 | 57 |
| 2019 | 0 | — | 6 | 41 |
| 2020 | 0 | — | 0 | 39 |
| 2021 | 2 | — | 1 | 101 |
| 2022 | 1 | — | 1 | 267 |
| 2023 | 3 | — | 0 | 1,087 |
| 2024 | 0 | — | 0 | 448 |
| 2025 | 2 | — | 0 | 8,588 |
| 2026 | 0 | — | 0 | — |
Planning a device in OSR? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report