Ipco Corp.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Ipco Corp.” (first 1976, latest 1987), across 17 product codes in 7 review panels. Median 510(k) review time under this name: 50 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 | 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 |
|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | 4 | 4 |
| HHD | Pad, Menstrual, Unscented | 3 | 3 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| EKP | Reamer, Pulp Canal, Endodontic | 1 | 1 |
| EKS | File, Pulp Canal, Endodontic | 1 | 1 |
| EKW | Broach, Endodontic | 1 | 1 |
Plus 7 more product codes.
Review panels
- Dental (6)
- Cardiovascular (4)
- Gastroenterology and Urology (4)
- Obstetrics and Gynecology (3)
- General and Plastic Surgery (3)
- Neurology (2)
- General Hospital (1)
Most recent Ipco Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871270 | PERFORM DENTURE BASE RESIN | EBF | 1987-05-29 | 59 |
| K850666 | STROBEX ULTRON ELECTROSURGE-DENTAL UNIT | EKZ | 1985-05-29 | 98 |
| K850906 | TACTILE PLUS DENTAL ELEVATORS | EMJ | 1985-04-12 | 38 |
| K842837 | SAFE & SOFT MAXI SHILEDS | HHD | 1984-10-15 | 87 |
| K842836 | SAFE & SOFT MINI PADS & MAXI PADS | HHD | 1984-10-15 | 87 |
| K842838 | SAFE & SOFT PANTY SHIELDS | HHD | 1984-10-05 | 77 |
| K841953 | ULTRA SHIELD BRIEFS | EYQ | 1984-07-19 | 66 |
| K840755 | MINIGARD DISPOSABLE LINERS | EYQ | 1984-04-13 | 50 |
| K840754 | MAXISHIELD INCONTINENCE CARE SYSTEM | EYQ | 1984-04-13 | 50 |
| K840753 | AMBEZE DISPOSABLE INCONTINENCE PANTS | EYQ | 1984-04-13 | 50 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ipco 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 Ipco Corp.?
FDA lists 23 510(k) clearances under the applicant name “Ipco Corp.” (first 1976, latest 1987), across 17 product codes in 7 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 Ipco Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ipco Corp. is 50 days.
Which FDA product codes appear under Ipco Corp.?
The most frequent FDA product codes under this applicant name are EYQ (Garment, Protective, For Incontinence, 4); HHD (Pad, Menstrual, Unscented, 3); LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 2).
Next steps
- See all 23 Ipco Corp. clearances with predicates and recalls
- Run predicate analysis for product code EYQ, Ipco 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.