Laerdal Mfg. Corp.: FDA clearances and approvals
Laerdal Mfg. Corp. has 5 FDA 510(k) clearances (first 1988, latest 1990), across 2 product codes in 1 review panel. Median 510(k) review time: 34 days.
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 |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 3 | 3 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 2 | 2 |
Review panels
- Cardiovascular (5)
Most recent Laerdal Mfg. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902429 | MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE | LDD | 1990-09-27 | 128 |
| K900169 | MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE | LDD | 1990-01-26 | 14 |
| K885186 | HEARTSTART 2000 DEFIBRILLATION ELECTRODE | LDD | 1989-02-23 | 71 |
| K883344 | HEARTSTART 1000S | MKJ | 1988-09-12 | 34 |
| K883341 | HEARTSTART 1000 | MKJ | 1988-09-12 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Laerdal Mfg. Corp..
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 Laerdal Mfg. Corp. have?
Laerdal Mfg. Corp. has 5 FDA 510(k) clearances (first 1988, latest 1990), across 2 product codes in 1 review panel.
How long does FDA take to clear Laerdal Mfg. Corp.'s 510(k)s?
The median time from FDA receipt to decision across Laerdal Mfg. Corp.'s cleared 510(k)s is 34 days.
What devices does Laerdal Mfg. Corp. make?
Its most frequent FDA product codes are LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 3); MKJ (Automated External Defibrillators (Non-Wearable), 2).
Has Laerdal Mfg. Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Laerdal Mfg. Corp. Related entities may recall under other names.
Next steps
- See all 5 Laerdal Mfg. Corp. clearances with predicates and recalls
- Run predicate analysis for product code LDD, Laerdal Mfg. Corp.'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.