Zmi Corp.: FDA clearances and approvals
Zmi Corp. has 8 FDA 510(k) clearances (first 1986, latest 1992), across 4 product codes in 2 review panels. Median 510(k) review time: 98 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 |
|---|---|---|---|
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 4 | 4 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 2 | 2 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 1 | 1 |
| LIH | Interferential Current Therapy | 1 | 1 |
Review panels
- Cardiovascular (7)
- Neurology (1)
Most recent Zmi Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915100 | BRINDLEY & SMITH ET-1000 | LIH | 1992-09-14 | 307 |
| K915159 | PEDIATRIC MULTI-FUNCTION ELECTRODES | DRF | 1992-02-07 | 85 |
| K913484 | ZOLL D-900 DEFIBRILLATOR | LDD | 1991-12-16 | 132 |
| K911956 | ZOLL PD-1400 PACER/DEFIBRILLATOR | DRO | 1991-07-31 | 90 |
| K895032 | ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES | LDD | 1989-10-12 | 65 |
| K885166 | ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES | DRO | 1989-05-01 | 139 |
| K873402 | ZOLL NTP-1200 PACER/DEFIBRILLATOR | DRO | 1987-11-23 | 91 |
| K855015 | NONINVASIVE TEMP. PACEMAKER NTP-1000 | DRO | 1986-03-31 | 105 |
Recalls
openFDA lists no recalls under a recalling firm named Zmi 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 Zmi Corp. have?
Zmi Corp. has 8 FDA 510(k) clearances (first 1986, latest 1992), across 4 product codes in 2 review panels.
How long does FDA take to clear Zmi Corp.'s 510(k)s?
The median time from FDA receipt to decision across Zmi Corp.'s cleared 510(k)s is 98 days.
What devices does Zmi Corp. make?
Its most frequent FDA product codes are DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), 4); LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 2); DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 1).
Has Zmi Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Zmi Corp. Related entities may recall under other names.
Next steps
- See all 8 Zmi Corp. clearances with predicates and recalls
- Run predicate analysis for product code DRO, Zmi 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.