Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Icn Pharmaceuticals, Inc. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
88 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022817 | COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II | Icn Pharmaceuticals, Inc. | 2002-11-22 | 88 | 0 |
| K951329 | IMMUCHEM GAL-MW EA | Icn Pharmaceuticals, Inc. | 1995-11-09 | 231 | 0 |
| K914530 | ICAN GT DRAINAGE BAG | Icn Pharmaceuticals, Inc. | 1991-12-18 | 68 | 0 |
| K914082 | SUAN FLAT DISSECTOR SPONGES | Icn Pharmaceuticals, Inc. | 1991-11-27 | 77 | 0 |
| K914086 | ICAN CYLINDRICAL SPONGES | Icn Pharmaceuticals, Inc. | 1991-10-09 | 28 | 0 |
| K914081 | ICAN COTTON RAYON BALLS | Icn Pharmaceuticals, Inc. | 1991-10-09 | 28 | 0 |
| K914083 | ICAN K DISSECTOR SPONGES | Icn Pharmaceuticals, Inc. | 1991-10-09 | 28 | 0 |
| K913446 | ICAN NEEDLE COUNTERS | Icn Pharmaceuticals, Inc. | 1991-09-13 | 42 | 0 |
| K904398 | WATER COLUMN RELIEF VALVE | Icn Pharmaceuticals, Inc. | 1991-07-09 | 287 | 0 |
| K770458 | BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. | Icn Pharmaceuticals, Inc. | 1977-05-10 | 63 | 0 |
| K770455 | GLUCOSE PROCEDURE, TEKPOINT DIRECT | Icn Pharmaceuticals, Inc. | 1977-05-03 | 56 | 0 |
| K770457 | CHOLESTEROL PROCEDURE, TEKPOINT TOTAL | Icn Pharmaceuticals, Inc. | 1977-05-03 | 56 | 0 |
| K770452 | PROTEIN PROCEDURE, TEKPOINT TOTAL | Icn Pharmaceuticals, Inc. | 1977-05-03 | 56 | 0 |
| K770450 | CHLORIDE PROCEDURE, TEKPOINT DIRECT | Icn Pharmaceuticals, Inc. | 1977-05-03 | 56 | 0 |
| K770449 | CALCIUM PROCEDURE, TEKPOINT DIRECT | Icn Pharmaceuticals, Inc. | 1977-05-03 | 56 | 0 |
| K770454 | CREATININE PROCEDURE, TEKPOINT | Icn Pharmaceuticals, Inc. | 1977-05-03 | 56 | 0 |
| K770451 | ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL | Icn Pharmaceuticals, Inc. | 1977-05-03 | 56 | 0 |
| K770456 | PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT | Icn Pharmaceuticals, Inc. | 1977-05-03 | 56 | 0 |
| K770453 | PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE | Icn Pharmaceuticals, Inc. | 1977-05-03 | 56 | 0 |
| K770459 | URIC ACID PROCEDURE, TEKPOINT DIRECT | Icn Pharmaceuticals, Inc. | 1977-04-29 | 52 | 0 |
| K770313 | REAGENT LDH-L, ENZYME | Icn Pharmaceuticals, Inc. | 1977-04-05 | 48 | 0 |
| K770310 | CHEMISTRY CONTROL, NORMAL | Icn Pharmaceuticals, Inc. | 1977-04-05 | 48 | 0 |
| K770319 | REAGENT CPK, ENZYME | Icn Pharmaceuticals, Inc. | 1977-04-05 | 48 | 0 |
| K770315 | BUN, ENZYMATIC | Icn Pharmaceuticals, Inc. | 1977-04-05 | 48 | 0 |
| K770318 | REAGENT GOT, ENZYME | Icn Pharmaceuticals, Inc. | 1977-04-05 | 48 | 0 |
| K770312 | CHEMISTRY CONTROL, ABNORMAL | Icn Pharmaceuticals, Inc. | 1977-04-05 | 48 | 0 |
| K770316 | ALKALINE PHOSPHATASE ENZYMATIC | Icn Pharmaceuticals, Inc. | 1977-03-30 | 42 | 0 |
| K770317 | GLUCOSE TRINDER, ENZYMATIC | Icn Pharmaceuticals, Inc. | 1977-03-30 | 42 | 0 |
| K770314 | REAGENT GPT, ENZYME | Icn Pharmaceuticals, Inc. | 1977-03-30 | 42 | 0 |
| K770311 | GLUCOSE REAGENT, ENZYMATIC | Icn Pharmaceuticals, Inc. | 1977-03-30 | 42 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda