Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JHM — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
62 daysmedian FDA review time
113 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120662 | PICCOLO HDL-CAPILLARY TEST SYSTEM | Abaxis, Inc. | 2012-04-24 | 50 | 0 |
| K081300 | DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | 2008-07-02 | 55 | 1 |
| K073072 | DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B | Dade Behring, Inc. | 2008-02-21 | 113 | 0 |
| K032798 | DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CART | Dade Behring, Inc. | 2003-10-30 | 51 | 0 |
| K022519 | LDL CHOLESTEROL (AUTOMATED) | Jas Diagnostics, Inc. | 2002-09-30 | 62 | 1 |
| K983849 | DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (AD | Dade Behring, Inc. | 1999-01-11 | 73 | 0 |
| K902935 | ROCHE COBAS READY HDL CHOLESTEROL REAGENT | Roche Diagnostic Systems, Inc. | 1990-09-27 | 86 | 0 |
| K841056 | HDL PRECIPITANT REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K780173 | LYPOPROTEIN CHOLESTEROL TEST KIT | Environmental Chemical Specialties | 1978-05-03 | 90 | 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