Medtronic Emergency Response Systems, Inc.: FDA clearances and approvals
Medtronic Emergency Response Systems, Inc. has 6 FDA 510(k) clearances (first 2004, latest 2007), across 2 product codes in 1 review panel. Median 510(k) review time: 86 days. openFDA lists 21 product recalls by a recalling firm named Medtronic Emergency Response Systems, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 5 | 5 |
| MSX | System, Network And Communication, Physiological Monitors | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Medtronic Emergency Response Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063510 | LIFEPAK 12 DEFIBRILLATOR/MONITOR | MKJ | 2007-01-26 | 67 |
| K063119 | LIFEPAK 20 DEFIBRILLATOR/ MONITOR | MKJ | 2006-12-22 | 71 |
| K052057 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | 2006-02-17 | 203 |
| K052854 | LIFENET EXCHANGE SYSTEM | MSX | 2006-01-20 | 101 |
| K042404 | LIFEPAK, MODEL 1000 | MKJ | 2005-12-22 | 475 |
| K041459 | LIFEPAK 12 DEFIBRILLATOR/MONITOR | MKJ | 2004-07-01 | 29 |
Recalls
21 product recalls in 15 recall events; 0 initiated in the last five years. Most recent: 2007-06-13.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Medtronic Emergency Response Systems, Inc. have?
Medtronic Emergency Response Systems, Inc. has 6 FDA 510(k) clearances (first 2004, latest 2007), across 2 product codes in 1 review panel.
How long does FDA take to clear Medtronic Emergency Response Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medtronic Emergency Response Systems, Inc.'s cleared 510(k)s is 86 days.
What devices does Medtronic Emergency Response Systems, Inc. make?
Its most frequent FDA product codes are MKJ (Automated External Defibrillators (Non-Wearable), 5); MSX (System, Network And Communication, Physiological Monitors, 1).
Has Medtronic Emergency Response Systems, Inc. had device recalls?
openFDA lists 21 product recalls in 15 recall events by a recalling firm whose name matches Medtronic Emergency Response Systems, Inc; the most recent began 2007-06-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Medtronic Emergency Response Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Medtronic Emergency Response Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.