Icn Pharmaceuticals, Inc.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Icn Pharmaceuticals, Inc.” (first 1977, latest 2002), across 28 product codes in 5 review panels. Median 510(k) review time under this name: 54 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 2 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
Plus 18 more product codes.
Review panels
- Clinical Chemistry (22)
- General and Plastic Surgery (4)
- General Hospital (2)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
Most recent Icn Pharmaceuticals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022817 | COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II | GEX | 2002-11-22 | 88 |
| K951329 | IMMUCHEM GAL-MW EA | JIA | 1995-11-09 | 231 |
| K914530 | ICAN GT DRAINAGE BAG | FRQ | 1991-12-18 | 68 |
| K914082 | SUAN FLAT DISSECTOR SPONGES | GDY | 1991-11-27 | 77 |
| K914086 | ICAN CYLINDRICAL SPONGES | GDX | 1991-10-09 | 28 |
| K914083 | ICAN K DISSECTOR SPONGES | GDY | 1991-10-09 | 28 |
| K914081 | ICAN COTTON RAYON BALLS | FRL | 1991-10-09 | 28 |
| K913446 | ICAN NEEDLE COUNTERS | MMK | 1991-09-13 | 42 |
| K904398 | WATER COLUMN RELIEF VALVE | CAF | 1991-07-09 | 287 |
| K770458 | BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. | CIG | 1977-05-10 | 63 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Icn Pharmaceuticals, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Icn Pharmaceuticals, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Icn Pharmaceuticals, Inc.?
FDA lists 30 510(k) clearances under the applicant name “Icn Pharmaceuticals, Inc.” (first 1977, latest 2002), across 28 product codes in 5 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 Icn Pharmaceuticals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Icn Pharmaceuticals, Inc. is 54 days.
Which FDA product codes appear under Icn Pharmaceuticals, Inc.?
The most frequent FDA product codes under this applicant name are GDY (Gauze/Sponge, Internal, X-Ray Detectable, 2); JJY (Multi-Analyte Controls, All Kinds (Assayed), 2); CAF (Nebulizer (Direct Patient Interface), 1).
Next steps
- See all 30 Icn Pharmaceuticals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GDY, Icn Pharmaceuticals, 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.