Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CDW — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
35 daysmedian FDA review time
84 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874532 | BLOOD UREA NITROGEN | Catachem, Inc. | 1988-01-05 | 63 | 0 |
| K871320 | FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 | American Research Products Co. | 1987-04-22 | 19 | 0 |
| K863425 | AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 | American Research Products Co. | 1986-10-01 | 27 | 0 |
| K861775 | TWIN BUN/GLUCOSE | Boehringer Mannheim Corp. | 1986-06-27 | 50 | 0 |
| K860419 | UREA NITROGEN REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-11 | 7 | 0 |
| K850937 | UREA | Dilab, Inc. | 1985-06-10 | 95 | 0 |
| K844156 | UREA NITROGEN REAGENT SET | Livonia Diagnostics, Inc. | 1984-11-13 | 20 | 0 |
| K841068 | UREA NITROGEN REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K822323 | ULTRACHEM BUN-UV, 65080 & 65081 | Harleco Diagnostics | 1982-09-02 | 30 | 0 |
| K821212 | UREA NITROGEN REAGENT SET | Omega Medical Electronics | 1982-07-22 | 86 | 0 |
| K813415 | UREA NITROGEN REAGENT SET | Anco Medical Reagents & Assoc. | 1981-12-31 | 24 | 0 |
| K802160 | BUN COLOR REAGENT & BUN ACID USED | Panmed, Inc. | 1980-10-10 | 32 | 0 |
| K800673 | SMAC REPLACEMENT REAGENTS/OF BUN-SERUM | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K781885 | SERUM, BLOOD UREA NITIOGEN | Fisher Scientific Co., LLC | 1978-12-20 | 43 | 0 |
| K781305 | UREA NITROGEN | Analytical & Research Chemicals, Inc. | 1978-08-31 | 34 | 0 |
| K780262 | DIRECT UREA NITROGEN TEST | Hycel, Inc. | 1978-04-05 | 47 | 0 |
| K771830 | BLOOD UREA NITROGEN BUN | Gamma Enterprises, Inc. | 1977-10-25 | 34 | 0 |
| K771312 | BLOOD UREA NITROGEN (BUN) REAGENT | Mallinckrodt Critical Care | 1977-08-03 | 16 | 0 |
| K771087 | UNIPAK BUN | Harleco | 1977-07-21 | 35 | 0 |
| K770470 | WORTHINGTON BUN | Worthington Biochemical Corp. | 1977-06-02 | 84 | 0 |
| K760478 | REAGENT, BUN (UREA NITROGEN) DETERM. | Simmler & Son, Inc. | 1976-10-29 | 73 | 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