Pmt Corp.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Pmt Corp.” (first 1983, latest 2020), across 19 product codes in 6 review panels. Median 510(k) review time under this name: 130 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 | 1 | 135 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 379 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 28 |
| 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 Pmt Corp. took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZL | Electrode, Depth | 3 | 3 |
| JXG | Shunt, Central Nervous System And Components | 3 | 3 |
| MDA | Elastomer, Silicone, For Scar Management | 3 | 3 |
| GYC | Electrode, Cortical | 2 | 2 |
| FNW | Pad, Kelly | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| FZS | Curette, Surgical, General Use | 1 | 1 |
| GAF | Spatula, Surgical, General & Plastic Surgery | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| GWM | Device, Monitoring, Intracranial Pressure | 1 | 1 |
Plus 9 more product codes.
Review panels
- Neurology (11)
- General and Plastic Surgery (8)
- General Hospital (3)
- Ophthalmic (2)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Pmt Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202542 | Allura Vaginal Stent | KXP | 2020-09-30 | 28 |
| K151790 | PMT Platinum Depthalon Depth Electrode | GZL | 2016-07-14 | 379 |
| K122376 | PMT TRUSCAN SURFACE ELECTRODE | GXY | 2012-12-19 | 135 |
| K090733 | PMT HALO SYSTEM | HAX | 2009-07-28 | 131 |
| K082474 | PMT SUBDURAL CORTICAL ELECTRODES | GYC | 2009-05-08 | 253 |
| K042901 | ENDOMARK STERILE INDIA INK | NBG | 2005-03-16 | 147 |
| K033730 | PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES | GZL | 2004-08-03 | 249 |
| K972597 | PMT NEW BEGINNINGS GELSHAPES & AMEND | MDA | 1997-10-01 | 82 |
| K970418 | PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) | GZL | 1997-04-29 | 84 |
| K964224 | STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE | GYC | 1997-03-19 | 147 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pmt Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Pmt Corp.?
FDA lists 26 510(k) clearances under the applicant name “Pmt Corp.” (first 1983, latest 2020), across 19 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pmt Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pmt Corp. is 130 days.
Which FDA product codes appear under Pmt Corp.?
The most frequent FDA product codes under this applicant name are GZL (Electrode, Depth, 3); JXG (Shunt, Central Nervous System And Components, 3); MDA (Elastomer, Silicone, For Scar Management, 3).
Next steps
- See all 26 Pmt Corp. clearances with predicates and recalls
- Run predicate analysis for product code GZL, Pmt Corp.'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.