FDA product code CBR: Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
CBR is the FDA product code for analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.). It is a Class II device, regulated under 21 CFR 868.1700 and reviewed by the Anesthesiology panel. FDA has cleared 5 510(k) submissions under CBR, from 5 different applicants. The average 510(k) review took 118 days (median 117). FDA has posted 3 recalls for CBR devices.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
| Device class | Class II |
| Regulation | 21 CFR 868.1700 |
| 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 CBR clearance
Top CBR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spacelabs Healthcare | 1 | 2011-10-05 |
| Spacelabs Medical, Inc. | 1 | 2006-04-19 |
| Spacelabs, Inc. | 1 | 1996-05-31 |
| Dalton Instrument Corp. | 1 | 1991-04-09 |
| Erich Jaeger, Inc. | 1 | 1985-09-03 |
Most recent CBR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K112173 | Spacelabs Healthcare | SPEACELABS MULTIGAS MODULE | 2011-10-05 | 69 |
| K053599 | Spacelabs Medical, Inc. | SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES | 2006-04-19 | 117 |
| K954962 | Spacelabs, Inc. | SPACELABS MEDICAL MULTIGAS ANALYZER | 1996-05-31 | 214 |
| K904843 | Dalton Instrument Corp. | OSCAR(TM) II CAPNOMETER & PULSE OXIMETER | 1991-04-09 | 166 |
| K853360 | Erich Jaeger, Inc. | N20 TEST | 1985-09-03 | 22 |
Recalls for CBR devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-06-18.
Frequently asked questions
What is FDA product code CBR?
CBR is the FDA product code for analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.). It is a Class II device, regulated under 21 CFR 868.1700 and reviewed by the Anesthesiology panel.
What device class is CBR?
Class II, regulation 21 CFR 868.1700. Typical premarket route: 510(k).
How long does a 510(k) take for product code CBR?
Across 5 cleared submissions the average was 118 days from receipt to decision (median 117).
Which companies have the most CBR clearances?
Spacelabs Healthcare (1); Spacelabs Medical, Inc. (1); Spacelabs, Inc. (1); Dalton Instrument Corp. (1); Erich Jaeger, Inc. (1).
Have CBR devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2014-06-18.
Next steps
- Run an FDA pathway report with predicate devices for product code CBR
- Run a recall and safety report across every CBR manufacturer
- Watch product code CBR 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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