Hdc Corp.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Hdc Corp.” (first 1983, latest 2007), across 16 product codes in 7 review panels. Median 510(k) review time under this name: 85 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 5 | 5 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 4 | 4 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 3 | 3 |
| CAZ | Anesthesia Conduction Kit | 2 | 2 |
| DYB | Introducer, Catheter | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| KZH | Introducer, Syringe Needle | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| ETN | Stimulator, Nerve | 1 | 1 |
Plus 6 more product codes.
Review panels
- General Hospital (16)
- Gastroenterology and Urology (4)
- Anesthesiology (3)
- Cardiovascular (3)
- Obstetrics and Gynecology (2)
- Ear, Nose and Throat (1)
- Microbiology (1)
Most recent Hdc Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071875 | V-CATH POLY PICC | LJS | 2007-11-05 | 122 |
| K023342 | NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG | KOI | 2004-03-02 | 512 |
| K033853 | MODIFICATION TO V-CATH POLY PICC | FOZ | 2004-01-14 | 34 |
| K032404 | SELDINGER SAFETY NEEDLE INTRODUCER | DYB | 2003-09-10 | 37 |
| K022752 | PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15 | CAZ | 2003-09-09 | 386 |
| K022099 | SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S | FOZ | 2002-09-20 | 85 |
| K010425 | EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) | KNF | 2001-03-15 | 30 |
| K994059 | CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 | CAZ | 2000-10-13 | 319 |
| K002770 | IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 | LJT | 2000-09-26 | 20 |
| K983119 | ENTERO-TEST HP, MODEL #102-01 | LIO | 1999-03-15 | 188 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hdc 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 Hdc Corp.?
FDA lists 30 510(k) clearances under the applicant name “Hdc Corp.” (first 1983, latest 2007), across 16 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 Hdc Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hdc Corp. is 85 days.
Which FDA product codes appear under Hdc Corp.?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 5); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 4); LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 3).
Next steps
- See all 30 Hdc Corp. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Hdc 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.