Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JMM — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
115 daysmedian FDA review time
225 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011052 | OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE | Ostex Intl., Inc. | 2001-07-30 | 115 | 0 |
| K993706 | ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY | Roche Diagnostics Corp. | 2000-07-24 | 265 | 1 |
| K992997 | OSTEOMARK NTX POC | Metrika, Inc. | 1999-11-09 | 63 | 0 |
| K990843 | SERUM CROSSLAPS ONE STEP ELISA | Osteometer Biotech A/S | 1999-07-09 | 116 | 0 |
| K983457 | OSTEOMARK NTX SERUM EIA | Ostex Intl., Inc. | 1999-02-02 | 125 | 0 |
| K983674 | VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGE | Ortho-Clinical Diagnostics, Inc. | 1999-01-29 | 101 | 0 |
| K972788 | CROSSLAPS ELISA | Devices and Diagnostics Consulting Group | 1998-12-22 | 512 | 0 |
| K981364 | PYRILINKS-D ASSAY KIT | Metra Biosystems, Inc. | 1998-08-13 | 120 | 0 |
| K980833 | IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 | Diagnostic Products Corp. | 1998-05-01 | 58 | 0 |
| K980518 | OSTEOMARK | Ostex Intl., Inc. | 1998-03-06 | 49 | 0 |
| K974260 | PYRILINKS-D ASSAY KIT | Metra Biosystems, Inc. | 1998-01-26 | 74 | 0 |
| K972580 | DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | 1997-09-22 | 74 | 0 |
| K971312 | IMMULITE PYRILINKS-D | Diagnostic Products Corp. | 1997-05-27 | 48 | 0 |
| K963251 | CIBA CORNING ACS;180 DPD ASSAY | Ciba Corning Diagnostics Corp. | 1996-10-15 | 57 | 0 |
| K961562 | OSTEOMARK | Ostex Intl., Inc. | 1996-07-11 | 80 | 0 |
| K960171 | ACTIVE CROSSLAPS ELISA | Diagnostic Systems Laboratories, Inc. | 1996-03-28 | 72 | 0 |
| K952320 | PYRILINKS-D ASSAY KIT | Metra Biosystems, Inc. | 1995-12-29 | 225 | 0 |
| K952506 | PYRILINKS ASSAY KIT | Metra Biosystems, Inc. | 1995-11-03 | 156 | 0 |
| K952026 | PYRILINKS POLYCLONAL ASSAY KIT | Metra Biosystems, Inc. | 1995-11-03 | 186 | 0 |
| K945946 | OSTEOMARK(R) | Ostex Intl., Inc. | 1995-05-08 | 154 | 0 |
| K770603 | HYPRONOSTICON TM | Organon, Inc. | 1977-09-02 | 156 | 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