Zoll Manufacturing Corporation: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Zoll Manufacturing Corporation” (first 2018, latest 2019), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 253 days. Since 2017 the median was 253 days, against 196 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 1 | 263 |
| 2019 | 2 | 216 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zoll Manufacturing Corporation took a median 253 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 196 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| MVK | Wearable Automated External Defibrillator | 1 | 0 |
Review panels
- Cardiovascular (4)
Most recent Zoll Manufacturing Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190939 | ZOLL Arrhythmia Management Sysyem | MHX | 2019-12-19 | 253 |
| K182093 | ZOLL ECG Analysis Software | DPS | 2019-01-28 | 178 |
| K172510 | µCor Heart Failure and Arrhythmia Management System | MHX | 2018-05-11 | 263 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P010030 | PMA | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST | 2001-12-18 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-09-12.
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 Medical Corporation, World Wide Headquarters (21 510(k)s)
- Zoll Circulation, Inc. (13 510(k)s)
- Zoll Respicardia, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zoll Manufacturing Corporation?
FDA lists 3 510(k) clearances under the applicant name “Zoll Manufacturing Corporation” (first 2018, latest 2019), plus 1 PMA decision, across 3 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 Manufacturing Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zoll Manufacturing Corporation is 253 days. Since 2017: 253 days, versus 196 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zoll Manufacturing Corporation?
The most frequent FDA product codes under this applicant name are MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 2); DPS (Electrocardiograph, 1); MVK (Wearable Automated External Defibrillator, 1).
Next steps
- See all 3 Zoll Manufacturing Corporation clearances with predicates and recalls
- Run predicate analysis for product code MHX, Zoll Manufacturing Corporation'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.