Welcon, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Welcon, Inc.” (first 1981, latest 2001), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| JOL | Catheter And Tip, Suction | 2 | 2 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 | 1 |
| FTA | Light, Surgical, Accessories | 1 | 1 |
| HFW | Clamp, Umbilical | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
| KYZ | Syringe, Irrigating (Non Dental) | 1 | 1 |
Review panels
- Gastroenterology and Urology (3)
- General Hospital (3)
- Obstetrics and Gynecology (1)
- General and Plastic Surgery (1)
Most recent Welcon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003402 | WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION | JOL | 2001-05-01 | 181 |
| K973734 | STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION | JOL | 1998-02-05 | 128 |
| K971764 | WELCON HUE-VU URINARY DRAINAGE BAG | KNX | 1997-07-29 | 77 |
| K912869 | WOMEN AND INFANT'S DELIVERY PACK | HFW | 1991-12-04 | 159 |
| K904158 | ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY | FCM | 1990-11-29 | 83 |
| K894397 | WELCON LIGHT HANDLE | FTA | 1989-08-10 | 21 |
| K830359 | STERILE CATHERIZATION PROCEDURE TRAYS | KOD | 1983-03-17 | 42 |
| K813027 | STERILE IRRIGATING SYRINGES, KITS,TRAY | KYZ | 1981-11-20 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Welcon, Inc..
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 Welcon, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Welcon, Inc.” (first 1981, latest 2001), across 7 product codes in 4 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 Welcon, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Welcon, Inc. is 80 days.
Which FDA product codes appear under Welcon, Inc.?
The most frequent FDA product codes under this applicant name are JOL (Catheter And Tip, Suction, 2); FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), 1); FTA (Light, Surgical, Accessories, 1).
Next steps
- See all 8 Welcon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOL, Welcon, Inc.'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.