FDA product code BSF: Absorber, Carbon-Dioxide
BSF is the FDA product code for absorber, carbon-dioxide. It is a Class I device, regulated under 21 CFR 868.5310 and reviewed by the Anesthesiology panel. FDA has cleared 8 510(k) submissions under BSF, from 7 different applicants. The average 510(k) review took 55 days (median 45). FDA has posted 6 recalls for BSF devices.
Classification
| Field | Value |
|---|---|
| Device name | Absorber, Carbon-Dioxide |
| Device class | Class I |
| Regulation | 21 CFR 868.5310 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BSF clearance
Top BSF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ohmeda Medical | 2 | 1985-07-15 |
| King Systems Corp. | 1 | 1995-03-24 |
| G & L Unltd. | 1 | 1984-06-07 |
| Airco/Ohio Medical Products | 1 | 1983-11-29 |
| Ohio Medical Products | 1 | 1982-05-28 |
2 more applicants have BSF clearances. See the full list in Caduvo.
Most recent BSF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K951093 | King Systems Corp. | KAB SYSTEM | 1995-03-24 | 15 |
| K852071 | Ohmeda Medical | OHMEDA GMS ABOSORBER | 1985-07-15 | 63 |
| K843422 | Ohmeda Medical | OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR | 1984-10-23 | 53 |
| K834535 | G & L Unltd. | NITROUS OXIDE RECYCLER | 1984-06-07 | 168 |
| K833452 | Airco/Ohio Medical Products | OHIO GMS ABSORBER | 1983-11-29 | 67 |
Recalls for BSF devices
6 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-07-22.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code BSF?
BSF is the FDA product code for absorber, carbon-dioxide. It is a Class I device, regulated under 21 CFR 868.5310 and reviewed by the Anesthesiology panel.
What device class is BSF?
Class I, regulation 21 CFR 868.5310. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BSF?
Across 8 cleared submissions the average was 55 days from receipt to decision (median 45).
Which companies have the most BSF clearances?
Ohmeda Medical (2); King Systems Corp. (1); G & L Unltd. (1); Airco/Ohio Medical Products (1); Ohio Medical Products (1).
Have BSF devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2019-07-22.
Next steps
- Run an FDA pathway report with predicate devices for product code BSF
- Run a recall and safety report across every BSF manufacturer
- Watch product code BSF 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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