FDA product code BWC: Needle, Emergency Airway
BWC is the FDA product code for needle, emergency airway. It is a Class II device, regulated under 21 CFR 868.5090 and reviewed by the Anesthesiology panel. FDA has cleared 14 510(k) submissions under BWC, from 10 different applicants. The average 510(k) review took 176 days (median 146). FDA has posted 2 recalls for BWC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Needle, Emergency Airway |
| Device class | Class II |
| Regulation | 21 CFR 868.5090 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BWC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 386 |
| 2020 | 1 | 277 |
Compare with all 510(k) review times · Search every BWC clearance
Top BWC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook, Inc. | 4 | 2002-02-21 |
| Cook Incorporated | 2 | 2017-02-17 |
| VBM Medizintechnik GmbH | 1 | 2020-10-30 |
| Teleflex Medical | 1 | 2013-11-06 |
| Smiths Medical | 1 | 2005-05-26 |
5 more applicants have BWC clearances. See the full list in Caduvo.
Most recent BWC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200190 | VBM Medizintechnik GmbH | ScalpelCric | 2020-10-30 | 277 |
| K160200 | Cook Incorporated | Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set | 2017-02-17 | 386 |
| K153761 | Cook Incorporated | Emergency Transtracheal Airway Catheter | 2016-09-22 | 267 |
| K130405 | Teleflex Medical | RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET | 2013-11-06 | 260 |
| K050166 | Smiths Medical | PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT | 2005-05-26 | 120 |
Recalls for BWC devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-03-05.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code BWC?
BWC is the FDA product code for needle, emergency airway. It is a Class II device, regulated under 21 CFR 868.5090 and reviewed by the Anesthesiology panel.
What device class is BWC?
Class II, regulation 21 CFR 868.5090. Typical premarket route: 510(k).
How long does a 510(k) take for product code BWC?
Across 14 cleared submissions the average was 176 days from receipt to decision (median 146).
Which companies have the most BWC clearances?
Cook, Inc. (4); Cook Incorporated (2); VBM Medizintechnik GmbH (1); Teleflex Medical (1); Smiths Medical (1).
Have BWC devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2026-03-05.
Next steps
- Run an FDA pathway report with predicate devices for product code BWC
- Run a recall and safety report across every BWC manufacturer
- Watch product code BWC 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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