Zoll Medical Corporation, World Wide Headquarters: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Zoll Medical Corporation, World Wide Headquarters” (first 2007, latest 2015), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 143 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 214 |
| 2013 | 0 | — |
| 2014 | 1 | 210 |
| 2015 | 1 | 452 |
| 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) | 17 | 17 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 2 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 | 1 |
Review panels
- Cardiovascular (21)
Most recent Zoll Medical Corporation, World Wide Headquarters 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133239 | ZOLL E SERIES | MKJ | 2015-01-16 | 452 |
| K133269 | ZOLL X SERIES | MKJ | 2014-05-22 | 210 |
| K120406 | ZOLL FULLY AUTOMATIC AED PLUS | MKJ | 2012-10-26 | 260 |
| K120907 | ZOLL R SERIES | MKJ | 2012-09-25 | 183 |
| K112761 | ZOLL PROPAQ MD | MKJ | 2012-04-25 | 216 |
| K112432 | ZOLL X SERIES | MKJ | 2012-03-21 | 211 |
| K111296 | ZOLL RESCUENETLINK | MSX | 2011-10-27 | 171 |
| K111594 | ZOLL E SERIES | MKJ | 2011-08-17 | 71 |
| K110361 | ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE | MKJ | 2011-03-08 | 29 |
| K110168 | ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE | MKJ | 2011-02-17 | 28 |
11 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2010-03-24.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- ZOLL Medical Corporation (63 510(k)s)
- Zoll Circulation, Inc. (13 510(k)s)
- Zoll Manufacturing Corporation (3 510(k)s)
- Zoll Respicardia, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zoll Medical Corporation, World Wide Headquarters?
FDA lists 21 510(k) clearances under the applicant name “Zoll Medical Corporation, World Wide Headquarters” (first 2007, latest 2015), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zoll Medical Corporation, World Wide Headquarters?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zoll Medical Corporation, World Wide Headquarters is 143 days.
Which FDA product codes appear under Zoll Medical Corporation, World Wide Headquarters?
The most frequent FDA product codes under this applicant name are MKJ (Automated External Defibrillators (Non-Wearable), 17); LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 2); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1).
Next steps
- See all 21 Zoll Medical Corporation, World Wide Headquarters clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Zoll Medical Corporation, World Wide Headquarters's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.