ZOLL Medical Corporation: FDA clearances and approvals
ZOLL Medical Corporation has 63 FDA 510(k) clearances (first 1993, latest 2024), plus 6 PMA decisions, across 16 product codes in 4 review panels. Median 510(k) review time: 170 days. Since 2017 its median was 288 days, against 182 days for all cleared 510(k)s in the same product codes. openFDA lists 19 product recalls by a recalling firm named ZOLL Medical Corporation. It is the industry lead sponsor of 26 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 117 |
| 2013 | 1 | 174 |
| 2014 | 5 | 238 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 174 |
| 2018 | 2 | 298 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 201 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 413 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, ZOLL Medical Corporation's cleared 510(k)s took a median 288 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 182 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 39 | 35 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 9 | 9 |
| DXJ | Display, Cathode-Ray Tube, Medical | 3 | 3 |
| CBK | Ventilator, Continuous, Facility Use | 2 | 2 |
| DTE | Pulse-Generator, Pacemaker, External | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| FRN | Pump, Infusion | 2 | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 1 | 1 |
Plus 6 more product codes.
Review panels
Most recent ZOLL Medical Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233486 | 731 Series Ventilator | CBK | 2024-12-13 | 413 |
| K202375 | ZOLL Propaq M | MWI | 2021-03-09 | 201 |
| K180482 | ZOLL Propaq M | MHX | 2018-11-30 | 280 |
| K172653 | Power Infuser | FRN | 2018-07-18 | 316 |
| K162832 | 731 Series Ventilators | CBK | 2017-08-02 | 295 |
| K170533 | Model 330 Multifunction Aspirator | BTA | 2017-04-18 | 54 |
| K142915 | ZOLL X Series | MKJ | 2014-12-03 | 57 |
| K141774 | ZOLL X SERIES | MKJ | 2014-11-19 | 140 |
| K140502 | ZOLL E SERIES ALS | LDD | 2014-11-06 | 252 |
| K133484 | ZOLL X SERIES | MKJ | 2014-08-01 | 261 |
53 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160033 | PMA | Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3 | 2018-12-07 |
| P160034 | PMA | Powerheart® AED G3 Pro | 2018-12-06 |
| P160022 | PMA | X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower | 2017-12-27 |
| P160015 | PMA | AED Plus and Fully Automatic AED Plus | 2017-05-26 |
| P110024 | PMA | RESQCPR SYSTEM | 2015-03-06 |
Recalls
19 product recalls in 12 recall events; 10 initiated in the last five years. Most recent: 2025-02-13.
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.
Device clinical trials
ZOLL Medical Corporation is the industry lead sponsor of 26 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT06556693: Janus II Feasibility (Recruiting, started 2025-08-12)
- NCT06570902: Prospective WCD Post CABG Registry (CABG Registry) (Recruiting, started 2024-09-23)
- NCT05505136: Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based Medications Changes (Completed, started 2022-08-30)
- NCT05604430: Pre-hospital Ventilation Clinical Study (Enrolling by invitation, started 2022-06-30)
- NCT05073354: Rapid Treatment of Shock Without Trauma (Completed, started 2021-06-29)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of ZOLL Medical Corporation's product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does ZOLL Medical Corporation have?
ZOLL Medical Corporation has 63 FDA 510(k) clearances (first 1993, latest 2024), plus 6 PMA decisions, across 16 product codes in 4 review panels.
How long does FDA take to clear ZOLL Medical Corporation's 510(k)s?
The median time from FDA receipt to decision across ZOLL Medical Corporation's cleared 510(k)s is 170 days. Since 2017: 288 days, versus 182 days for all cleared 510(k)s in the same product codes.
What devices does ZOLL Medical Corporation make?
Its most frequent FDA product codes are MKJ (Automated External Defibrillators (Non-Wearable), 39); LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 9); DXJ (Display, Cathode-Ray Tube, Medical, 3).
Has ZOLL Medical Corporation had device recalls?
openFDA lists 19 product recalls in 12 recall events by a recalling firm whose name matches ZOLL Medical Corporation; the most recent began 2025-02-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 63 ZOLL Medical Corporation clearances with predicates and recalls
- Run predicate analysis for product code MKJ, ZOLL Medical Corporation'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.