Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JIW — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
59 daysmedian FDA review time
126 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973055 | WAKO CH50 LINEARITY SET | Wako Chemicals USA, Inc. | 1997-09-25 | 41 | 0 |
| K970396 | HUMAN CHORIONIC GONADOTROPIN CALIBRATOR | Dade Chemistry Systems, Inc. | 1997-02-20 | 17 | 0 |
| K910255 | FLOW CYTOMETRY FITC/PE COMPENSATION KIT | Sigma Diagnostics, Inc. | 1991-04-03 | 71 | 0 |
| K902575 | SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) | Diagnostic Products Corp. | 1990-10-04 | 115 | 0 |
| K902294 | ACCUSCAN MICROBEAD STANDARDS | Sigma Chemical Co. | 1990-07-03 | 42 | 0 |
| K892213 | ACS COLLOID OSMOTIC PRESSURE CALIBRATOR | Analytical Control Systems, Inc. | 1989-06-21 | 79 | 0 |
| K883389 | RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD | Reagents Applications, Inc. | 1988-12-14 | 126 | 0 |
| K882220 | CALIBRATION KIT | King Diagnostics, Inc. | 1988-08-02 | 68 | 0 |
| K880654 | AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 | American Research Products Co. | 1988-06-07 | 111 | 0 |
| K880610 | UNIMETER CALIBRATION KIT | Boehringer Mannheim Corp. | 1988-03-24 | 41 | 0 |
| K854028 | AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER | Verified Medical Research, Inc. | 1985-12-02 | 62 | 0 |
| K851450 | FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM | Flow Cytometry Standards Corp. | 1985-09-16 | 158 | 0 |
| K852260 | QUICK-CHEM CALIBRATION SET | Seragen Diagnostics, Inc. | 1985-07-22 | 59 | 0 |
| K812220 | NEPHELOMETRIC SOLID TURBIDITY STANDARD | Hyland Therapeutic Div., Travenol Laboratories | 1981-08-18 | 12 | 0 |
| K801300 | DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) | E.I. Dupont DE Nemours & Co., Inc. | 1980-07-08 | 36 | 0 |
| K800304 | CENTRIFICHEM FILTER CALIBRATION SET | Union Carbide Corp. | 1980-03-12 | 29 | 0 |
| K790643 | CENTRIFICHEM FILTER CALIBRATION SET | Union Carbide Corp. | 1979-05-23 | 54 | 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