FDA product code BSJ: Mask, Gas, Anesthetic
BSJ is the FDA product code for mask, gas, anesthetic. It is a Class I device, regulated under 21 CFR 868.5550 and reviewed by the Anesthesiology panel. FDA has cleared 51 510(k) submissions under BSJ, from 37 different applicants. The average 510(k) review took 55 days (median 29). FDA has posted 1 recall for BSJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Mask, Gas, Anesthetic |
| Device class | Class I |
| Regulation | 21 CFR 868.5550 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for BSJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 326 |
Compare with all 510(k) review times · Search every BSJ clearance
Top BSJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medipart Jerry Alexander | 6 | 1986-08-01 |
| Life Design Systems, Inc. | 3 | 1989-01-24 |
| Vital Signs, Inc. | 3 | 1983-07-07 |
| Hans Rudolph, Inc. | 2 | 1995-01-27 |
| Rondex Products, Inc. | 2 | 1990-08-22 |
32 more applicants have BSJ clearances. See the full list in Caduvo.
Most recent BSJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K163277 | Revolutionary Medical Devices, Inc. | SuperNO2VA Device | 2017-10-13 | 326 |
| K953107 | Medical Marketing Concepts | ANESTHESIA/RESPIRATORY FACE MASK | 1995-08-15 | 43 |
| K953295 | Mallinckrodt Medical | ANESTHESIA FACE MASK | 1995-08-11 | 28 |
| K952689 | Owens-Brigam Medical Co. | BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK | 1995-07-11 | 29 |
| K951043 | Promedic, Inc. | AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK | 1995-06-07 | 92 |
Recalls for BSJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-09-12.
Frequently asked questions
What is FDA product code BSJ?
BSJ is the FDA product code for mask, gas, anesthetic. It is a Class I device, regulated under 21 CFR 868.5550 and reviewed by the Anesthesiology panel.
What device class is BSJ?
Class I, regulation 21 CFR 868.5550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BSJ?
Across 51 cleared submissions the average was 55 days from receipt to decision (median 29).
Which companies have the most BSJ clearances?
Medipart Jerry Alexander (6); Life Design Systems, Inc. (3); Vital Signs, Inc. (3); Hans Rudolph, Inc. (2); Rondex Products, Inc. (2).
Have BSJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-09-12.
Next steps
- Run an FDA pathway report with predicate devices for product code BSJ
- Run a recall and safety report across every BSJ manufacturer
- Watch product code BSJ 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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