Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hycel, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
64 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K802422 | HYCEL TRIGYCERIDE II TEST | Hycel, Inc. | 1980-10-06 | 0 | 0 |
| K790335 | HYCEL M | Hycel, Inc. | 1979-02-27 | 6 | 0 |
| K782116 | KETOSTEROID TEST, HYCEL-17 | Hycel, Inc. | 1979-01-26 | 30 | 0 |
| K782176 | HYCEL LDH-INT TEST | Hycel, Inc. | 1979-01-26 | 29 | 0 |
| K782101 | HYCEL COUNTER 222 | Hycel, Inc. | 1979-01-03 | 16 | 0 |
| K782102 | HYCEL COUNTER 211 | Hycel, Inc. | 1979-01-03 | 16 | 0 |
| K782100 | HYCEL COUNTER 333 | Hycel, Inc. | 1979-01-03 | 16 | 0 |
| K780946 | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER | Hycel, Inc. | 1978-07-27 | 48 | 0 |
| K781004 | HMA URIC ACID TEST | Hycel, Inc. | 1978-07-27 | 41 | 0 |
| K780464 | LELECTIVE KINETIC SYSTEM-60 | Hycel, Inc. | 1978-05-03 | 42 | 0 |
| K780262 | DIRECT UREA NITROGEN TEST | Hycel, Inc. | 1978-04-05 | 47 | 0 |
| K772426 | 17-HYDROXY TEST | Hycel, Inc. | 1978-01-30 | 34 | 0 |
| K771259 | ALBUMIN TEST, HMA ALBUMIN TEST | Hycel, Inc. | 1977-08-22 | 42 | 0 |
| K771343 | LDH-INT TEST | Hycel, Inc. | 1977-08-10 | 21 | 0 |
| K771353 | PLATELET COUNTER & HEMATOCRIT ACCES. | Hycel, Inc. | 1977-08-10 | 19 | 0 |
| K771154 | CPK-INT TEST | Hycel, Inc. | 1977-07-21 | 23 | 0 |
| K771107 | COUNTER 700 & HC-700 HEMO 0 REF. | Hycel, Inc. | 1977-07-11 | 21 | 0 |
| K770803 | HEMOTOLOGY PRODU&TS (5 IN ALL) | Hycel, Inc. | 1977-07-05 | 64 | 0 |
| K770643 | CREATININE TEST, SUPER SEVENTEEN | Hycel, Inc. | 1977-06-24 | 81 | 0 |
| K770748 | TEST, FERROZINE IRON & IRON BINDING | Hycel, Inc. | 1977-06-01 | 40 | 0 |
| K770393 | PROPANE, HIGH PURITY, INSTRUMENT GRADE | Hycel, Inc. | 1977-04-26 | 57 | 0 |
| K760468 | TEST, REFORMULATED HYCEL HMA CALCIUM | Hycel, Inc. | 1976-11-01 | 75 | 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