FDA product code BWB: Forceps, Tube Introduction
BWB is the FDA product code for forceps, tube introduction. It is a Class I device, regulated under 21 CFR 868.5780 and reviewed by the Anesthesiology panel. FDA has cleared 6 510(k) submissions under BWB, from 3 different applicants. The average 510(k) review took 38 days (median 46). FDA has posted 1 recall for BWB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Tube Introduction |
| Device class | Class I |
| Regulation | 21 CFR 868.5780 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BWB clearance
Top BWB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eastmed Enterprises, Inc. | 3 | 1988-11-14 |
| Imm Enterprises , Ltd. | 2 | 1984-02-04 |
| Imed Corp. | 1 | 1982-03-26 |
Most recent BWB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884584 | Eastmed Enterprises, Inc. | TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS | 1988-11-14 | 12 |
| K880318 | Eastmed Enterprises, Inc. | ROVENSTEIN FORCEPS | 1988-03-21 | 55 |
| K880319 | Eastmed Enterprises, Inc. | MAGILL FORCEPS | 1988-03-21 | 55 |
| K840313 | Imm Enterprises , Ltd. | CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV | 1984-02-04 | 11 |
| K834169 | Imm Enterprises , Ltd. | OP-CON SURGICAL INSTRUMENT #9 | 1984-01-17 | 57 |
Recalls for BWB devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-02-23.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code BWB?
BWB is the FDA product code for forceps, tube introduction. It is a Class I device, regulated under 21 CFR 868.5780 and reviewed by the Anesthesiology panel.
What device class is BWB?
Class I, regulation 21 CFR 868.5780. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BWB?
Across 6 cleared submissions the average was 38 days from receipt to decision (median 46).
Which companies have the most BWB clearances?
Eastmed Enterprises, Inc. (3); Imm Enterprises , Ltd. (2); Imed Corp. (1).
Have BWB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-02-23.
Next steps
- Run an FDA pathway report with predicate devices for product code BWB
- Run a recall and safety report across every BWB manufacturer
- Watch product code BWB 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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