FDA product code CBZ: Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
CBZ is the FDA product code for analyzer, ion, hydrogen-ion (ph), blood-phase, indwelling. It is a Class II device, regulated under 21 CFR 868.1170 and reviewed by the Anesthesiology panel. FDA has cleared 10 510(k) submissions under CBZ, from 8 different applicants. The average 510(k) review took 90 days (median 85). FDA has posted 1 recall for CBZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling |
| Device class | Class II |
| Regulation | 21 CFR 868.1170 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CBZ clearance
Top CBZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Puritan Bennett Corp. | 2 | 1993-06-01 |
| Biochem International, Inc. | 2 | 1981-02-02 |
| Terumo Cardiovascular Systems Corp. | 1 | 2002-06-20 |
| Diametrics Medical, Ltd. | 1 | 1997-09-23 |
| Abbott Laboratories | 1 | 1992-03-30 |
3 more applicants have CBZ clearances. See the full list in Caduvo.
Most recent CBZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K020967 | Terumo Cardiovascular Systems Corp. | TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM | 2002-06-20 | 87 |
| K970906 | Diametrics Medical, Ltd. | PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR | 1997-09-23 | 195 |
| K931112 | Puritan Bennett Corp. | MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI | 1993-06-01 | 89 |
| K920061 | Abbott Laboratories | HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM | 1992-03-30 | 83 |
| K912030 | 3M Company | CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED | 1991-10-30 | 176 |
Recalls for CBZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-06-23.
Frequently asked questions
What is FDA product code CBZ?
CBZ is the FDA product code for analyzer, ion, hydrogen-ion (ph), blood-phase, indwelling. It is a Class II device, regulated under 21 CFR 868.1170 and reviewed by the Anesthesiology panel.
What device class is CBZ?
Class II, regulation 21 CFR 868.1170. Typical premarket route: 510(k).
How long does a 510(k) take for product code CBZ?
Across 10 cleared submissions the average was 90 days from receipt to decision (median 85).
Which companies have the most CBZ clearances?
Puritan Bennett Corp. (2); Biochem International, Inc. (2); Terumo Cardiovascular Systems Corp. (1); Diametrics Medical, Ltd. (1); Abbott Laboratories (1).
Have CBZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2006-06-23.
Next steps
- Run an FDA pathway report with predicate devices for product code CBZ
- Run a recall and safety report across every CBZ manufacturer
- Watch product code CBZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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