FDA product code CBQ: Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
CBQ is the FDA product code for analyzer, gas, enflurane, gaseous-phase (anesthetic concentration). It is a Class II device, regulated under 21 CFR 868.1500 and reviewed by the Anesthesiology panel. FDA has cleared 22 510(k) submissions under CBQ, from 12 different applicants. The average 510(k) review took 178 days (median 168).
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) |
| Device class | Class II |
| Regulation | 21 CFR 868.1500 |
| 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 CBQ clearance
Top CBQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Datex Division Instrumentarium Corp. | 7 | 1993-07-21 |
| Ohmeda Medical | 4 | 1997-01-17 |
| Datascope Corp. | 2 | 1993-08-25 |
| Philips Medizin Systeme Boeblingen GmbH | 1 | 2004-04-29 |
| Agilent Technologies, GmbH | 1 | 2000-05-19 |
7 more applicants have CBQ clearances. See the full list in Caduvo.
Most recent CBQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040917 | Philips Medizin Systeme Boeblingen GmbH | PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B | 2004-04-29 | 21 |
| K994188 | Agilent Technologies, GmbH | MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 | 2000-05-19 | 158 |
| K962648 | Ohmeda Medical | OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR | 1997-01-17 | 193 |
| K931439 | Ohmeda Medical | OHMEDA MODEL 5330 ANESTHETIC MONITOR | 1993-10-19 | 211 |
| K926451 | Datascope Corp. | DATASCOPE MULTINEX II | 1993-08-25 | 244 |
Recalls for CBQ devices
openFDA lists no recalls for product code CBQ.
Frequently asked questions
What is FDA product code CBQ?
CBQ is the FDA product code for analyzer, gas, enflurane, gaseous-phase (anesthetic concentration). It is a Class II device, regulated under 21 CFR 868.1500 and reviewed by the Anesthesiology panel.
What device class is CBQ?
Class II, regulation 21 CFR 868.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code CBQ?
Across 22 cleared submissions the average was 178 days from receipt to decision (median 168).
Which companies have the most CBQ clearances?
Datex Division Instrumentarium Corp. (7); Ohmeda Medical (4); Datascope Corp. (2); Philips Medizin Systeme Boeblingen GmbH (1); Agilent Technologies, GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CBQ
- Run a recall and safety report across every CBQ manufacturer
- Watch product code CBQ 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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