Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CBZ — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
195 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020967 | TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM | Terumo Cardiovascular Systems Corp. | 2002-06-20 | 87 | 1 |
| K970906 | PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYST | Diametrics Medical, Ltd. | 1997-09-23 | 195 | 0 |
| K931112 | MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI | Puritan Bennett Corp. | 1993-06-01 | 89 | 0 |
| K920061 | HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM | Abbott Laboratories | 1992-03-30 | 83 | 0 |
| K912030 | CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED | 3M Company | 1991-10-30 | 176 | 0 |
| K912428 | PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT | Puritan Bennett Corp. | 1991-08-09 | 70 | 0 |
| K884228 | CDI(R) 2000 BLOOD GAS MONITOR | Cardiovascular Devices, Inc. | 1989-01-30 | 115 | 0 |
| K862114 | KHURI REGIONAL TISSUE PH MONITOR | Vascular Technology Incorporated | 1986-06-25 | 22 | 0 |
| K803260 | SENSOMAT MUSCLE/TISSUE PH | Biochem International, Inc. | 1981-02-02 | 40 | 0 |
| K803014 | SENSOMAT | Biochem International, Inc. | 1980-12-22 | 24 | 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